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11/13/15 - China
China announces 10-point drug reform program

CFDA has issued a bulletin (2015 No.230) announcing 10 reforms covering the review and approval process for generic as well as new drugs, and clinical trial applications. The reforms also include the establishment of uniform centralized review standards, an accelerated review procedure for drugs that meet urgent medical needs, and a restricted drugs list. Drug sponsors will be allowed to withdraw an application that does not meet the criteria for approval, and a process is to be established for a sponsor to request a re-examination of an application that would allow input from legal experts and patient representatives.


11/12/15 - China
11 drugs by 8 companies denied approval due to fraud

China’s FDA has denied marketing approval applications for 11 drugs submitted by 8 local companies due to unauthorized modification of clinical trial data and fraud that was uncovered following onsite inspections by the agency. Additional drug sponsors have voluntarily withdrawn 317 marketing approval applications after their internal investigations uncovered irregularities in the clinical data supporting the applications. The agency had requested in July that industry conduct its own inspection of clinical trial data.


10/12/15 - China
On-site GMP inspection guidance issued for local agencies

CFDA has issued a notice to local regulatory agencies with specific guidance on the conduct of on-site good manufacturing practices (GMP) compliance inspections of manufacturers of sterile medical devices, implantable devices and in vitro diagnostic (IVD) products. The guidance covers inspections for production site verification as well as production license changes, and sets deadlines of 6 months for rectification of any issues uncovered for license application inspections and 30 days for rectification where the inspection was done for production changes.


9/17/15 - India
Ministry of Health and State governments collaborate to strengthen drug regulation at the local level

India’s Ministry of Health and State governments have signed a Memorandum of Understanding (MOU) designed to strengthen the regulation of drugs at the local level through national government subsidies. The preamble to the MOU underscores the importance of the pharmaceutical sector to India’s economy, and identifies the following six concerns relating to drug regulation at the local level:
• Inadequate or weak drug control infrastructure at the State level
• Inadequate drug testing facilities
• Non-uniformity in legislative and regulatory enforcement
• Lack of training of regulatory officials
• Inadequacy of databases and IT services
The MOU took effect on September 1, 2015, and will remain in force until March 31, 2018.


9/16/15 - US
Califf nominated to head FDA

President Obama yesterday announced his nomination of Dr. Robert Califf, a leading cardiologist and researcher, as the next head of FDA. Dr. Califf joined FDA earlier this year as Deputy Commissioner for Medical Products and Tobacco, and had previously served in various capacities at Duke University School of Medicine and the Duke University Medical Center since 1982. Although Califf’s confirmation by the Senate is expected, it will be interesting to see if his clinical research ties to Big Pharma companies such as Merck, Bristol-Myers Squibb, Eli Lilly and Novartis raise any questions. In that regard, it is noteworthy that a vocal critic of industry, Cleveland Clinic’s Dr. Nissen, has endorsed the nomination, as has Ellen Sigal, the chair of Friends of Cancer Research. No date has been set as yet for the confirmation hearings.


9/11/15 - China
CFDA releases results of self-audit

According to a CFDA bulletin released on September 9, mandated clinical trial self-audit reports revealed that of the 82 organizations conducting bioequivalence and phase I trials, 7 had more than 20 trials ongoing; of the 383 organizations conducting phase II and III trials, 13 were undertaking more than 60 trials each; and of 126 CROs, 6 were running more than 20 trials each. The self-audit reports were to be submitted to the agency by August 25 by the sponsors of more than 1,600 drug registration applications. CFDA has informed companies that it will review the audit reports and conduct on-site inspections without notice, as needed.


8/21/15 - China
China’s State Council announces sweeping drug and device approval reforms

In a circular released on August 18, China’s State Council announced the launch of sweeping reforms of the country’s current drug and medical device review and approval systems. The focus of the changes is on improving the efficiency of the review system,encouraging the development of innovative drugs and devices, resolving the drug application backlog by the end of 2016, improving the quality of generic drugs, and creating a more transparent review and approval process.

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7/22/15 - China
GMPs issued for sterile devices, IVDs, and implants

China's FDA has issued three separate appendices to the established good manufacturing practice (GMP) regulations which establish special requirements for the production of sterile devices, in vitro diagnostics, and implantable devices. The new GMPs take effect as of October 1, 2015. Under the Medical Device Supervision and Administration Regulations (MDSAR), device manufacturers with production facilities in China are required to organize their quality control systems in accordance with device GMPs. Failure to comply with GMPs carries potential penalties such as revocation of the license to manufacture in China.


7/17/15 - China
Revised device classification rules to take effect January 1, 2016

CFDA has finalized revised medical device classification rules that will take effect as of January 1, 2016. The revised rules classify devices based on the level of risk that they pose, factoring in structural features, intended use, and whether the device comes into human contact. There will be four primary classification categories - passive, active, invasive, and reusable surgical devices – as well as a special classification category for combination devices.


7/8/15 - Australia
Hip, knee and shoulder implant regulatory transition period ends

Australia’s Therapeutic Goods Administration (TGA) has announced that the three-year transition period for filing a request for reclassification into Class III of marketed total and partial hip, knee or shoulder joint replacements expired on June 30, 2015. Companies that have not submitted reclassification applications must stop marketing such devices and submit marketing authorization applications. Companies that need further clarification as to the status of an implant should contact the TGA.


7/8/15 - China
CFDA issues unannounced drug and device inspection rules

China’s FDA has issued new rules on unannounced inspections of drug and device manufacturing facilities, research facilities, as well as aspects of product marketing and use. The new enforcement policy is to take effect as of September 1, 2015. It sets forth the conditions that would trigger such inspections such as alleged serious violations of quality management or inadequate adverse event monitoring. Moreover, it establishes guidance as to how inspectors are to conduct the inspections and advises as to the regulatory action that may be needed to address any violations that are uncovered.

Local authorities instructed to increase supervision of device clinical trials
CFDA has issued a bulletin to local regulators to increase supervision of medical device clinical trials and to implement enforcement action where violations are uncovered. Local authorities are instructed to ensure that trial sponsors submit the proper documentation in the form of a Medical Device Clinical Trials record by that includes investigational review board (IRB) review and approval of the trial. Where violations are uncovered, the authorities should implement appropriate sanctions against the trial sponsor.


7/5/15 - China
Good supply practices regulation revised

The CFDA has issued a revised good supply practices (GSP) regulation, which mandates implementation of the regulation and was approved on May 18, 2015. The purpose of the revision is to ensure adherence to such quality management practices as adequate personnel training, implementation of a documents management system, adherence to proper cold chain transport and storage, computer systems, and the verification of supplier during procurement to prevent counterfeit products from entering the supply chain. The regulation also mandates compliance with the specifications for quality assurance set forth in China’s 2015 Pharmacopeia.  

6/12/15 - India
'Made in India' policy calls for device regulatory body and price controls

A proposed National Medical Device Policy calls for the creation of a new National Medical Devices Authority (NMDA) that would grant a 'Made in India' mark for locally produced devices that conform to efficacy, safety, and quality control standards set by the new agency. The ‘Made in India’ mark underscores the government’s goal of fostering the growth of an innovative local medical device sector, and such devices would be granted preference in the government procurement process. The Draft Policy would also bring certain devices like stents and implants under a price control process similar to the one covering pharmaceuticals, in order to address recent cases of price gouging.


5/29/15 - China
Drug and device registration fees increased

China’s FDA (CFDA) has announced a revised interim fee structure for the registration of drugs and new interim registration fees for medical devices. The revised fee for drugs has been set at 624,000 yuan (approx. $100,600), which the agency notes is only 64% of the fees charged in Australia, 35.5% of those in Canada, 33.7% in Japan, and 5.2% in the United States. The decision to increase fees was initiated based on the recommendations of a third party accounting firm hired by the the National Development and Reform Commission at the Ministry of Finance.


5/6/15 - EUnetHTA
Final economic evaluation guidance issued

EUnetHTA has issued final guidance that is intended to provide a common European framework for conducting health economic evaluations, and it draws on existing methodological guidelines for conducting such evaluations in the 33 partners of the EUnetHTA. The target group for the guidance are the health economists and health technology assessors in Europe who either review economic evaluations that have been performed by others, or who perform de novo economic evaluations. The guidance is designed to enhance the ability to share economic evaluations, especially with those countries that do not have a methodological guideline for health economic evaluations.


5/6/15 - China
CFDA fast tracks approval for two innovative devices

China’s FDA (CFDA) has issued marketing authorization approvals for two new medical devices under the ‘Fast Track Approval Process for Innovative Medical Devices’ that went into effect on March 1, 2014. The two devices are Engineering Company’s acellular corneal medical device to restore stroma integrity and CapitalBio Corporation’s nucleic acid amplification microfluidic chip analyzer. The time from submission to approval took 4 months and 22 days.


4/8/15 - US
Former FDA Commissioner Hamburg lands at IOM

Former FDA Commissioner Margaret Hamburg has landed at the Institute of Medicine (IOM) as its ‘foreign secretary’ in charge of building relationships with counterpart medical and scientific institutes in other countries. Hamburg is well suited for her new role, given her extensive foreign travel while she was at FDA, particularly in the last two years of her tenure. Hamburg has also been an outspoken advocate of the need for FDA as well as foreign regulatory agencies to keep on top of new scientific and medical breakthroughs, such as the development of genetic markers for personalized medicines and the promise of stem cell therapies.

Hamburg’s call for a global regulatory entity at the European Medicines Agency’s 20th anniversary celebration last week in London could be a hint as to one of her key priorities while she is at the IOM over the next four years. A move in that direction would be in keeping with the trend over the last four years, which have seen the birth of a plethora of new international drug regulatory groups. Most notable among these are the International Coalition of Medicines Regulatory Authorities (ICMRA), created in 2014 for the heads of the regulatory agencies in Australia, Brazil, Canada, China, Japan, Korea, Mexico, New Zealand, Nigeria, South Africa and the United States, and the International Pharmaceutical Regulators Forum (IPRF), created in 2013, which includes working staff from the agencies of the ICMRA member countries.


4/2/15 - Canada
Final guidance on resolution of submission-related disputes released

Health Canada has issued final guidance how drug submission-related disputes between the applicant and the agency are to be addressed. Based on feedback received on the draft version, the right to request reconsideration will be possible for Priority Review Requests and Requests for Advanced Consideration. However, the preparation of Summary Basis of Reconsideration Decisions (SBRD) will cease, and the use of Scientific Advisory Committees (SAC) to resolve a dispute under reconsideration will be discontinued. The management of the process is being transferred to the Food and Drugs Act Liaison Office (FDALO), located in the Communications and Public Affairs Branch of Health Canada.


4/2/15 - India
Drug industry asked to assist development of computer-based regulatory system

The Central Drugs Standard Control Organization (CDSCO) has requested all pharmaceutical-related associations in India to submit nominations for information technology experts to work with the agency in developing an electronic system for filing, processing, and tracking the status of submitted applications. Work on the new system began in December 2014 and the software is being developed by the Center for Development of Advanced Computing (CDAC).


3/26/15 - India
Local companies can now supply API for local R&D

India’s Central Drugs Standard Control Organization (CDSCO) has issued an order outlining the procedure for Indian active pharmaceutical ingredient (API) makers to obtain No Objection Certificates (NOCs) for supplying Indian manufacturers that develop and produce trial batches of drugs for export. The CDSCO noted that prior to the amended NOC procedure, local formulators of trial batches for export were required to import the API needed for their work because there was no pathway in place for Indian manufacturers to obtain permission to provide the API. Companies that obtain a NOC for supplying local formulators must label the API as “Not for medicinal use, for the purpose of test and analysis only.”


3/6/15 - India
CDSCO seeking input on accreditation standards for ethics committees, investigators, and sites

India’s Central Drugs Standard Control Organization (CDSCO) is requesting input on standards for the accreditation of Ethics Committees, clinical trial investigators, and trial sites developed by India’s Quality Council. The standards stem from a recommendation by the Ministry of Health’s Expert Committee Chaired by Prof. Chaudhury that clinical trials should be conducted only at accredited sites by accredited investigators with the oversight of accredited Ethics Committees. The mandate of the Expert Committee was to revamp the drug and clinical trial approval process, as well as the process for banning drugs.


3/6/15 - China
Biosimilar guidance finalized

The CFDA has finalized the draft biosimilar guidance - Biosimilar drug development and evaluation guidelines - that was issued by the agency for comment on October 29, 2014. According to the CFDA February 28 notice, the guidance has been amended taking into consideration the comments that were submitted on the draft, which focused primarily on product evaluation criteria. The guidance lays out the basic principles of biosimilar drug development and evaluation, such as recommended non-clinical and clinical studies and quality control. The agency says it believes the guidance will reduce corporate R&D time and cost.


2/27/15 - India
New criteria for waiver of Phase III trials in India proposed

India’s Drugs Technical Advisory Board (DTAB) has recommended granting a waiver from the need to conduct a Phase III clinical trial in India, if a drug is approved for marketing in “a well regulated country” - such as the European Union or the US – and a four-year post-marketing surveillance plan has been approved by the Central Drugs Standard Control Organization (CDSCO).

Prior to granting a waiver, the CDSCO would have to obtain input from experts in the therapeutic area for which the drug is indicated. The DTAB recommendation is similar to what the Chaudhry Expert Committee, tasked with overhauling the drug regulatory system in India, had proposed to the Ministry of Health. The Ministry countered that such a waiver should be limited to national health emergencies and for drugs indicated for rare diseases.


2/25/15 - India
CDSCO cracks down on fraud

India’s Central Drugs Standard Control Organization (CDSCO) is cracking down on companies and consultants who have submitted to the agency falsified data in support of fixed dose combination (FDC) and new drug applications. CDSCO has banned Kivi Labs and Arion Healthcare from submitting any applications to the agency for a period of five years because the companies were found to have submitted false data in support of FDCs. The agency has also ordered a review of all applications submitted by Dr. Shahbaz, the owner of Meher Pharma International, after it was discovered that he had submitted “fabricated documents” in support of a number of new drug applications. Shabaz can no longer submit any applications to the agency.


2/20/15 - India
Access to Tamiflu facilitated

In an effort to facilitate access to medications to combat swine flu (H1N1), the CDSCO has requested that local regulators update a 2009 list of the names of those who are licensed to sell, stock or distribute oseltamavir phosphate (Tamiflu) in India. The number of swine flu cases now exceeds 11,000 nationwide, with more than 700 deaths reported. In New Delhi, the government has licensed 40 new drug stores to sell Tamiflu tablets, as the number of H1N1 cases nears 2,000 with more than six deaths.


2/5/15 - Canada
Canada Patent Office stiffens patent hurdle

Canada’s patent office has amended its regulations to incorporate changes mandated by recent court rulings in Gilead and ViiV Healthcare (2012) and the Pfizer and Actelion cases (2014), which stiffened the patent hurdle for patent claimants. Under the changes made to section 3.2.1 (Patent Eligibility), a patentee may be denied the right to list a patent for a drug if it did not specifically identify in the patent claims the medicinal ingredients within a drug by name or by chemical structure, even though the medicinal ingredient may be generally covered within the scope of the patent claims. Moreover, amended Section 3.2.1. (Scope and Application), implements the “patent bargain” ruling of the court for full disclosure of a patentable invention to the public (the so-called “quid”) in exchange for grants of exclusive rights for a limited period of time to the inventor (the “quo”).


1/29/15 - India
Indian regulator proposes formal pre-submission meeting process

India’s Central Drugs Standard Control Organization (CDSCO) has proposed a new Pre-submission Meetings (PSM) process with agency staff and experts concerning applications for approval of clinical trials, new drugs, medical devices and other regulated products. According to the agency, the new PSM system is intended to help applicants understand the requirements of the regulatory pathway for approval that are appropriate in each circumstance. The proposal specifies that any agreement reached between an applicant and the agency as to the requirements for a specific approval pathway will only apply to that particular application. PSMs are not mandatory, and will involve payment of a fee, although the proposal does not mention what the amount of the fee will be. The deadline for comments on the proposal is February 9, 2015.


1/29/15 - UK
NICE recommends eculizumab (Soliris) for treating very rare life-threatening blood disorder

The UK's National Institute for Health and Care Excellence (NICE) has issued final guidance recommending eculizumab (Soliris, Alexion) for funding for treating atypical Haemolytic Uraemic Syndrome (aHUS). The guidance is the first to be produced as part of

NICE’s highly specialized technologies program to evaluate treatments for very rare conditions.

aHUS is a life-threatening disease affecting around 200 people in England, with 20–30 new patients diagnosed with the condition each year. It causes inflammation of blood vessels and the formation of blood clots throughout the body. People with aHUS are at constant risk of sudden and progressive damage to, and failure of, vital organs, particularly the kidneys.

NICE Chief Executive Sir Andrew Dillon commented that, given the cost of eculizumab, the Committee felt that the budget impact could be reduced by exploring the potential for adjusting the dose of the drug and stopping treatment. This is reflected in the guidance which recommends eculizumab should be funded only if important conditions are met, including the development of rules for starting and stopping treatment for clinical reasons.


1/23/15 - Brazil
New law gives Anvisa greater flexibility to prioritize product-related health risks

Brazil has enacted a new law that introduces a number of measures to the regulatory framework that will allow Anvisa and the National Health Surveillance System greater flexibility to prioritize their work according to risk. The new law includes provisions for extension of registration validity for up to 10 years depending on product characteristics and risks, rather than the fixed 5-year period that has been in place until now; use by Anvisa of inspection reports from health agencies in other countries and the ability to accredit other institutions to carry out inspections; and expansion of the network of laboratories that conduct inspections and post-market surveillance.

The law also updates the rules on transfers of registration ownership between companies and those governing waivers of Business Operation Authorization renewal, and creates a simplified registration renewal for drugs that have been on the market for at least 10 years and for which there have been no reports of significant adverse effects or ineffectiveness.

Anvisa’s Board has already begun taking steps to adapt the current rules to the new law, beginning with the topics to be addressed in the agency’s next Regulatory Agenda.


1/22/15 - China
China adopts Milestone device Good Supply Practices
China’s FDA has issued the country’s first Good Supply Practices (GSP) regulations that apply to all Class 1, 2 and 3 medical device distributors, as well as third party logistics service providers for medical devices. The GSP regulations establish minimum standards for device procurement, delivery acceptance, storage, sales, transportation, and after-sales services. Distributors must implement quality management systems that cover all aspects of the distribution process, such as the quality and training of personnel, cold storage and cold-chain transportation, as well as computer information and record keeping.


1/22/15 - India
CDSCO proposes uniform format for requesting approval of bioequivalence studies for export purposes

India’s Central Drugs Standard Control Organization (CDSCO) is soliciting input on draft guidance that establishes a uniform format for filing requests for the approval of bioequivalence studies that are to be conducted in India on drugs intended for export. The uniform formats cover study requests for: a new molecule approved in another country but not India; drugs approved in India within one year and more than one year but less than four; drugs in modified release form irrespective of their approval status; and, so-called old drugs approved in India for more than four years. The deadline for comments is January 25, 2015.


1/22/15 - EMA
EMA seeks input on access to clinical trial database information

EMA is seeking input on proposed rules and options that will govern the exceptions to public access to the information entered into the new clinical trial portal and database, as required by the European Clinical Trial Regulation. The exceptions to public access listed in the Regulation are the protection of: personal data, commercially confidential information, confidential communication between Member States, and the supervision of clinical trials by Member States. The deadline for comments is February 18, 2015.

EMA publishes Individual Case Safety Reports guide
EMA has published a guide to support the implementation of a new international standard for the safety monitoring of medicines known as ISO ICSR, which will standardize the format for Individual Case Safety Reports (ICSRs) of suspected drug side effects when it takes effect on July 1, 2016. The guide explains the ICSR electronic submission process, the format and content of an ICSR, as well as report validation and classification, and data quality principles. It also will facilitate the implementation of the EudraVigilance system, the European database of all suspected adverse reactions reported with medicines authorized in the European Economic Area (EEA), which includes the EU, Iceland, Liechtenstein, and Norway.


1/16/15 - China
China revises device GMPs

China’s regulator has issued revised current medical device good manufacturing practices (GMPs) that require manufacturers to implement quality management systems covering product design and development, manufacturing, and sales, including after-sales services. Manufacturers must also maintain records on product design and development, production, testing, purchasing, sales, and after-sale services. In addition, the quality management system must also cover the operation, cleaning, and maintenance of the manufacturing equipment and facilities. The revised GMPs take effect March 1, 2015.


1/16/15 - UK
NICE final draft guidance recommends simeprevir (Olysio) in combination with peginterferon alfa and ribavirin for treating hepatitis C

In final draft guidance NICE has recommended simeprevir (Olysio, Janssen) as a treatment option for some people with chronic hepatitis C. Simeprevir has a marketing authorisation for treating two forms of hepatitis C, genotype 1 which is the most common type of chronic hepatitis C in England, accounting for around 46% of diagnoses; and Genotype 4, which accounts for around 4% of diagnoses. The draft guidance recommends simeprevir, in combination with peginterferon alfa and ribavirin, as an option for treating both genotypes 1 and 4 chronic hepatitis C in adults. Simeprevir is administered orally and works by inhibiting the replication of the hepatitis C virus.

Commenting on the draft guidance, NICE Centre for Health Technology Evaluation Director Professor Carole Longson said: “The previous draft guidance did not recommend simeprevir for treating genotype 4 chronic hepatitis C and asked the company for more information on its use for this group of patients. Based on the information received the independent Appraisal Committee concluded that simeprevir, in combination with peginterferon alfa and ribavirin, is a cost effective treatment option for people with genotypes 1 and 4 chronic hepatitis C.

More data on the use of simeprevir in combination with sofosbuvir to treat chronic hepatitis C in people who can’t tolerate or aren’t eligible for treatment with interferon is due to become available soon, and recommendations on this treatment combination will be developed in separate guidance.

The draft guidance is now with consultees, who have the opportunity to appeal against it. Final guidance on simeprevir in combination with peginterferon alfa and ribavirin for chronic hepatitis C is due to be published in February 2015.


1/15/15 - China
China approves world’s first inactivated Sabin polio vaccine

China’s regulator has announced the marketing approval of the world’s first Sabin strain inactivated polio vaccine. The vaccine was developed independently by China’s Institute of Medical Biology at the Academy of Medical Sciences. The agency acknowledges the assistance of the World Health Organization (WHO), the US Centers for Disease Control (CDC), Japan’s National Institute of Infectious Diseases (NIID), the European Medicines Agency (EMA), and the UK, in the review of the vaccine. China intends to provide the vaccine to developing countries through the WHO’s polio eradication program.


1/15/15 - Brazil
Daklinza approved for hepatitis C

Anvisa has approved a registration application for Bristol Myers Squibb’s Daklinza (daclatasvir) for the treatment of hepatitis C. According to Brazil’s Ministry of Health, about 3% of the population may be infected with the hepatitis C virus, which corresponds to 185 million people. Prevalence in the Brazilian population is between 1.4% and 1.7%, mainly among the over-45s. According to the survey, some 15,800 people are currently being treated for hepatitis C through the country’s public health service, Brazil being one of the few developing countries in the world that provides free diagnostic testing and universal treatment for viral hepatitis.

Health Ministry distributes 3-in-1 combination product for treatment of HIV/AIDS
This week, Brazil’s Ministry of Health is sending to all Brazilian states a 3-in-1 product 3 for the treatment of patients with HIV and AIDS. The drug combination - tenofovir (300 mg), lamivudine (300 mg) and efavirenz (600 mg) - should benefit 100 000 new patients with HIV and AIDS. The Ministry of Health has invested 36 million reals (about $13.7 million) in the acquisition of 7.3 million tablets. The stock is enough to serve patients for the next twelve months.


1/15/15 - UK
Diclofenac tablets now only available as a prescription medicine

The MHRA has announced that as of today diclofenac tablets, used to treat pain and inflammation, will no longer be available without a prescription, due to a small risk of heart problems. Topical products such as gels will remain available for purchase from pharmacies.

In August 2013 the MHRA consulted on the continued availability of oral diclofenac as a pharmacy medicine in the UK following a European review that found there was a small but significant increased risk of cardiovascular side effects associated with the drug. The product information for diclofenac was updated to reflect this new information.This evidence was evaluated by the MHRA’s Commission on Human Medicines, which concluded that these side effects cannot be ruled out even when the medicine is taken for a short time or at a lower dose.A recall to the pharmacy level only has been issued in order to avoid any further sales without prescription.


1/8/15 - India
India proposes major overhaul of Drugs and Cosmetics Act

India’s Department of Health and Welfare has released for public comment a 42-page draft bill that would expand and overhaul the country’s Drugs and Cosmetics Act. Major changes proposed by the draft bill are the addition of a new chapter in the law on clinical trials and ethics committees, the regulation of medical devices and the creation of a Drug, Cosmetic and Medical Devices Consultative Committee. Other changes include an extensive definitions section and a new section on penalties for violations of the law. Comments on the draft bill can be submitted until January 12, 2015.


1/5/15 - India
India to create new Expert Committees for clinical trial and product approvals review

India’s Central Drugs Standard Control Organization (CDSCO) has posted the names of the experts chosen by the Ministry of Health to be seated on 25 advisory panels. The members of the advisory panels may also be seated on Subject Expert Committees for the evaluation of applications for clinical trials and approval of new drugs and new medical devices. These Subject Expert Committees will be made up of 7 medical experts and one pharmacologist.

New clinical trial and GMP requirements coming in 2015
India’s Central Drugs Standard Control Organization (CDSCO) has issued its planned policy initiatives for 2015, which include amendments to the Drugs and Cosmetics Act concerning clinical trials and good manufacturing practices (GMPs) for drugs and devices. The agency also plans to expand public-private partnerships, publish a revised National List of Essential Medicines (NLEM), and finalize accreditation standards for Clinical Trial Ethics Committees, Investigators, and Clinical Trials.


12/10/14 - India
CDSCO posts plan to upgrade the national regulatory system

The CDSCO has posted the Ministry of Health plan to upgrade the national and state-level drug regulatory system over the next three years, with particular emphasis on the construction of new, and the upgrade of existing, drug and medical product testing laboratories. The plan requires the signing of a Memorandum of Understanding (MOU) between the CDSCO and state governments setting out the objectives and timeframes for completing the regulatory infrastructure upgrades. The main objective of the plan is the strengthening of the ability of the CDSCO and the states to perform the requisite testing of drugs and other medical products.


12/4/14 - US
Generics to get FDA support for REMS protected samples

Generic companies will be able to obtain samples of REMS covered reference drugs with the support of the FDA, according to the agency’s draft guidance slated for publication on November 5, 2014. The FDA support would be available if the agency found that the bioequivalence study protocol for a generic contains safety protections comparable to the risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) that cover the reference listed drug (RLD). The generic sponsor could then request the FDA to send a letter to the REMS holder indicating that the agency would not consider it to be a violation of REMS for the company to provide samples of the drug to the ANDA applicant or its agent. The deadline for comments on the draft guidance is February 3, 2015.


12/3/14 - India
India seeks input on draft revisions to device GMPs

India’s CDSCO is seeking input on draft revisions to the good manufacturing practices for medical devices set forth in Schedule M-III of the country’s Drug and Cosmetic Act. The revisions aim to bring the GMP requirements for medical devices and in-vitro diagnostics into alignment with international GMP standards. They require that the quality system for the manufacture of devices and IVDs conform to the BIS 15579/ISO 13485 international standard, an internationally recognized quality standard which states the requirements of the quality management system for the design and manufacture of medical devices.

For combination devices, the manufacturing process for the drug/biologics must conform to the GMP requirements set out in Schedule M of India’s Drug and Cosmetic Act governing pharmaceutical GMPs, but the process of loading the drug/biologics into the device and thereafter will be governed by the proposed device/IVD GMP standards.

The deadline for comments on the draft GMP revisions is December 17, 2014.


12/1/14 - India
CDSCO revising clinical trial standards

India’s CDSCO is seeking input on draft revised accreditation standards for clinical trials that were prepared by the National Accreditation Board for Hospitals and Healthcare Providers (NABH) and the Quality Council of India, in consultation with various stakeholders. The draft sets out the criteria for the accreditation of ethics committees, investigators and the sites where clinical trials are to be carried out. The deadline for comments is December 15, 2014.


21/1/14 - Italy
Italy suspends two batches of Novartis' Fluad vaccine following deaths

AIFA has suspended the use of two batches of Novartis’ Fluad influenza vaccine following 12 deaths in Italy over the past three weeks after receiving the vaccine. A preliminary analysis by the agency of the cases so far shows:
• In 8 cases (67%) the patients were over 80 years old.
• 7 cases were female and 5 male.
• In 8 cases death occurred in the first 24 hours.
• In 8 cases death occurred from cardiovascular causes.
• The reports came from 6 regions: Sicily (2); Molise (1); Puglia (2); Tuscany (2); Emilia Romagna (2); Lombardy (2); Lazio (1).
• The lots involved have gone from the initial 2 to 6 for a total of 1,357,399 doses.
• Reports of the timing of death range from same day to 13 days later.

AIFA has requested a discussion of the case by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee, which is set to begin today and go through Thursday, December 4th.

The EMA notes in a statement on its website that there "is so far no evidence to suggest a causal link between the vaccine and the reported adverse events", adding that the suspension is a "precautionary measure."

For the current vaccination campaign, 4 million doses of Fluad have been distributed in Italy, and the vaccine has also been distributed in Austria, Germany and Spain.


11/26/14 - Australia
Regulatory reform a priority for TGA in 2014-15

Regulatory reform is a priority for 2014-2015 according to the business plan released today by Australia’s Therapeutic Goods Administration (TGA). Among the reforms targeted by the TGA for the coming year is the implementation of a fast track process for the marketing approval of new drugs and devices, as well as a process for facilitating patient access to unapproved drugs and devices. The TGA also intends to expand its postmarket oversight capabilities through the establishment of clinical quality registers for cardiac devices and breast implants, and sentinel reporting sites. In addition, the agency plans to target ways in which it can “recognize risk assessments, standards and determinations of trusted regulators” more extensively when approving drugs and devices.


11/20/14 - US
HHS proposes sweeping changes to clinical trial reporting

The Department of Health and Human Services (HHS) has proposed extensive amendments to the regulation that established and is instituting a new policy requiring the reporting of all trials funded by the National Institutes of Health (NIH). Developed by NIH in close coordination with the FDA, the 400+ page Federal Register notice details procedures for meeting the requirements established by the Food and Drug Administration Amendments Act of 2007 to improve public access to clinical trial information. The proposed rule changes include:
• A streamlined approach for determining which trials are subject to the proposed regulations and who is responsible for submitting required information.
• Expansion of the set of trials subject to summary results reporting to include trials of unapproved products.
• Additional data elements that must be provided at the time of registration (not later than 21 days after enrolling the first participant) and results submission (generally not later than 12 months after completion).
• Clarified procedures for delaying results submission when studying an unapproved, unlicensed, or uncleared product or a new use of a previously approved, licensed, or cleared product and for requesting extensions to the results submission deadline for good cause.
• More rapid updating of several data elements to help ensure that users of have access to accurate, up-to-date information about important aspects of a clinical trial.
• Procedures for timely corrections to any errors discovered by the responsible party or by the Agency as it processes submissions prior to posting.


11/19/14 - China
CFDA agrees to bilateral GMP cooperation with Canada and Brazil

At the November 18 meeting in Beijing of the International Conference of Drug Regulatory Authorities (ICDRA), the Deputy Director of the China FDA, Wu Zhen, signed a Memorandum of Understanding on drug good manufacturing practices (GMPs), which included bilateral collaboration on international issues, with the Assistant Deputy Minister of Health Canada. During the ICDRA meeting, the CFDA also agreed with Brazil’s National Health Surveillance Agency, Anvisa, to enhance bilateral cooperation on GMPs and further the role of BRIC countries in global regulatory initiatives.


11/18/14 - US
FDA proposes definition of “first generic” for review priority

FDA has proposed a definition for the term “first generic” for the purpose of identifying those ANDAs that are eligible for expedited review by the agency, which is a commitment that FDA made to the generic industry during the GDUFA negotiations. According to the proposed definition, a “first generic” would be (1) a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product. The agency cautions that ANDA submissions that originally mete the criteria for a “first generic” submission could lose the priority status if subsequently the validity of a patent is upheld in litigation, which would block the ANDA approval until the originator’s patent expires. The deadline for comments is December 19, 2014.

11/17/14 - Canada
Canada Launches Ebola Trial

The Canadian Institutes of Health Research (CIHR) and the Public Health Agency of Canada (PHAC) have provided funding for a Phase I clinical trial using Canada’s Ebola vaccine (VSV-EBOV). The Canadian Immunization Research Network (CIRN) is conducting the trial with 40 volunteers ages 18-65 in Halifax, Nova Scotia. The trial is taking place concurrently with trials on the same vaccine in the United States in order to expedite the move to clinical trials in larger populations. The Canadian Immunization Research Network (CIRN) was created in 2014 to enhance Canada’s ability to rapidly test new vaccines and foster the exchange of information among vaccine researchers and government decision makers.


11/5/14 - Australia
TGA issues Q&A on new international regulators coalition

Australia’s Therapeutic Goods Administration (TGA) issued a Q&A on November 5 concerning the recently created International Coalition of Medicines Regulatory Authorities (ICMRA). The purpose of creating this new international coalition is the need for a coordinating international platform for drug regulatory authorities that can promote informed risk-based allocation of national regulatory resources. The current membership includes the heads of drug regulatory authorities in: Australia, Brazil, Canada, China, the European Union, France, Germany, Ireland, Italy, Japan, Korea, Mexico, the Netherlands, New Zealand, Nigeria, Singapore, South Africa, Switzerland, the United Kingdom, and the United States, with the World Health Organization (WHO) as an observer. Health Canada is the ICMRA interim Chair and interim secretariat, with Ireland and Japan as interim Vice-Chairs.


11/5/14 - UK
NICE recommends Boehringer Ingelheim’s Pradaxa for treating and preventing blood clots

In draft guidance issued October 31, The UK's National Institute for Health and Care Excellence (NICE) has recommended Boehringer Ingelheim’s anti-blood clotting drug Pradaxa (dabigatran) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism in adults. DVT occurs when a blood clot forms in the deep veins of the leg or pelvis, which can limit the flow of blood through the affected vein and cause the leg to swell. If the blood clot dislodges and travels to the lungs, this can lead to a pulmonary embolism (PE) when the clot blocks the blood supply to the lungs. People with suspected DVT or PE are generally treated immediately an anticoagulant, most commonly with injections of low molecular weight heparin (LMWH). When the diagnosis has been confirmed, patients are prescribed an oral anticoagulant such as warfarin for varying lengths of time depending on their risk of having another DVT or PE, as well as their risk of bleeding.

NICE proposes to recommend GSK’s Arzerra with chlorambucil for untreated chronic lymphocytic leukaemia
NICE has issued new preliminary draft guidance for consultation which proposes recommending GlaxoSmithKline’s Arzerra (ofatumumab) with chlorambucil for treatment of chronic lymphocytic leukaemia (CLL). CLL is the most common form of leukaemia in England, with around 2,700 people diagnosed each year. Although half of the people who need treatment are not able to use the standard first-line treatment of fludarabine combination therapy, another product recommended by NICE, bendamustine, is available. Ofatumumab works by attaching itself to the surface of B cells, which activates the immune system to kill the B cells.

GlaxoSmithKline has agreed to provide ofatumumab to the NHS at a discount. The consultation is open for comment until 25 November 2014, after which a new draft guidance will be issued.


10/29/14 - India
CDSCO reduces API stability testing data requirement

India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on October 22 cutting the long term stability testing data requirement for active pharmaceutical ingredient (API) exports to the EU from 12 months to 6 months, on three batches. The accelerated stability data requirement – 6 months – remains the same.

In order to obtain the Written Confirmation Certificate from the CDSCO that is required by the EU, the API exporter must establish that there were no major changes from the specifications under the lowered testing threshold. Moreover, the exporter must submit a stability protocol that commits the manufacturer to an ongoing stability program and requires the manufacturer to assign retest/expiry dating according to ICH guidelines.


10/29/14 - Switzerland
Swissmedic approves Ebola vaccine trial at the CHUV in Lausanne

On October 27, Swissmedic approved the application for a trial with an experimental Ebola vaccine at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne. Given the severity of the Ebola epidemic, the application, submitted at the end of September 2014, was handled by the agency as a priority. The trial, which will include 120 volunteers, is receiving considerable support from the World Health Organization (WHO) and continues a series of trials that began in the USA, the UK and Mali.

The vaccine, based on a genetically modified chimpanzee adenovirus (Zaire Ebola Chimpanzee Adenovirus, cAd3-EBO-Z), consists of viruses that have the genetic blueprint of a defined Ebola protein, but that cannot replicate. It will initially be administered to healthy volunteers who will then be deployed as medical staff in the fight against the Ebola epidemic in West Africa. The trial will test the safety of the vaccine and its capacity to provide an immune response. The results from the CHUV trial will – together with the results of other centers involved – provide the basis for planning subsequent, much larger trials.

Since the vaccine is a genetically modified organism, Swissmedic has also consulted the Federal Office of Public Health, the Federal Office for the Environment and the Swiss Expert Committee for Biosafety.


10/22/14 - India
CDSCO task force to tackle reform

India’s Central Drugs Standard Control Organization (CDSCO) has announced the formation of a Task Force to undertake a comprehensive review of the existing processes, procedures, forms and licenses used by the agency, and to “simplify and make them … user friendly”. The Task Force includes four former CDSCO officials and the agency’s current Deputy Drugs Controller, and the announcement also asks five industry trade associations to submit nominations for the industry representation. The announcement gives the Task Force three months from the date of its first meeting to get the job done, and emphasizes that all revisions must be compliant with the agency’s recently approved online system.


10/22/14 - UK
NICE final guidance recommends GSK’s Tafinlar (dabrafenib) for melanoma

NICE has issued final guidance recommending GlaxoSmithKline’s Tafinlar (dabrafenib) for the treatment of melanoma which has metastasiazed or cannot be completely removed by surgery, and which tests positive for the BRAF V600 mutation. Tafinlar is a biological therapy which kills cancer cells with the BRAF V600 mutation, which can slow or stop the growth of the cancer.

Commenting on the guidance, Professor Carole Longson, centre for health technology evaluation director at NICE, said: "For a long time the treatments available for skin cancer which has spread have been very limited. However, in recent years a number of breakthrough treatments that potentially significantly improve the prognosis for some people with malignant melanoma have become available. NICE has already recommended vemurafenib and ipilimumab and we are pleased to add dabrafenib to the list of options available for this type of skin cancer. NICE was able to publish this final guidance quickly and speed up access - in less than 3 months since the committee first met to discuss the treatment."


10/17/14 - Australia
Australia lowers market access hurdle for local device industry Australia’s Therapeutic Goods Administration (TGA) announced on October 15 that Australian manufacturers of low risk medical devices would be given the option to obtain marketing approval using conformity assessment certification obtained from European notified bodies. The option provides a quicker and less expensive way to market for local manufacturers of Class II and Class III medical devices and IVDs, like Australian-made hearing aids, joint implants, and devices used for in-vitro fertilization procedures, as long as the device is already marketed in Europe. High-risk devices will not be eligible for this option. According to the Ministry of Health, the new TGA regulations stem from the government’s Industry Innovation and Competitiveness Agenda, whose goal is to enhance the competitiveness of Australia’s industrial sectors such as the device industry.


10/10/14 - Brazil
Anvisa amends rule governing purchases of similar medicines

Starting in January prescriptions in Brazil will be able to be filled with similar drugs instead of branded medicines listed in the prescription. ANVISA approved on October 9 the standard that sets out the procedures for establishing the interchangeability of similar drugs with the reference medicinal product, and under the new rule, similars that already have proven pharmaceutical equivalence with the reference product category can declare in the package insert that they are substitutes for the brand. The proposal adopted yesterday differs significantly from what was presented in January this year, when discussions on the text began. The original proposal provided that the equivalent remedy would have to have its own package, with inscription “EQ” and a price least 35% lower than the reference drug.

Besides the change in the package insert, pharmacies will display at the counter lists so that the consumer can see the name of the reference product and its equivalent before making a purchasing choice. Later this year, all medications considered similar have to submit bioequivalence and bioavailability tests to show that they are equivalent to the reference product. These tests are already required for generic drugs, but most similars have already accomplished this step. Currently, only generics can replace brand-name drugs, but the law that created generics required that by the end of this year, all similars would have to meet the same requirements.

Anvisa updates BA/BE test best practices certification
Anvisa has released an updated Certification of Good Practice for the conduct of bioavailability/bioequivalence (BA/BE) studies. One of the changes on the new certification is the validity period, which was changed to two years from the expiration of the previous certificate. Good practices are the set of practices that must be adopted by research centers in order to ensure quality and compliance the BA/BE studies that compare pharmacokinetic or pharmacodynamic parameters between the test drug and the reference drug or comparator. BA/BE for registration and post-registration of medicines are required to be performed in certified test centers.


10/9/14 - EU
European Commission issues final opinion on metal-on-metal hip implants

The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) has issued its final opinion on the safety of Metal-on-Metal (MoM) joint replacements with a particular focus on hip implants. SCENIHR concludes that all types of MoM implants release metals that may lead to local and/or systemic adverse health effects, and implants with large diameters (large-head) show the highest incidence of such reactions. Moreover, large-head MoM implants used in total hip replacement should be avoided due to their high failure risk.

The Opinion noted further that due to the fact that MoM hip implants pose a higher health risk when compared with alternative implants, their use of should be carefully considered on a case-by case basis. SCENIHR also recommends systematic follow-up for all MoM implant patients and all implants, including clinical and radiographic investigation at intervals depending on local protocols. In particular, metal ion determination is recommended for large-head MoM total hip replacement on a routine basis and for hip resurfacing patients at least in the first postoperative years. In that regard, SCENIHR endorses the overall MoM strategy outlined in the European Consensus Statement.


10/8/14 - EU
EMA identifies pediatric oncology drug needs

The European Medicines Agency’s Pediatric Committee (PDCO) has released for public comment an inventory of needed pediatric research with marketed oncology drugs. The draft list was developed after reviewing the authorized indications and formulations of the medicinal products that have been approved for use in the European Union. Specific oncology drugs are included in the draft according to the following identified pediatric research needs for each of the listed drugs: • Therapeutic use - even though the medicines are used in pediatric oncology practice, for which some data support the relevance of their mechanism of action • Off-label use – where a wider use occurs in pediatric oncology practice (other types of tumors and lines of treatment), for which additional data are needed • Therapeutic needs for oral administration drug forms • Improving dosing recommendations


10/8/14 - Brazil
Anvisa demonstrates drug tracking platform

Anvisa has unveiled the first drug tracking platform - a step in the implementation of the National Drug Control System (SNCM) - providing an interface between the agency and the holders of drug registrations. The system was demonstrated on October 8 on the premises of Libbs Pharmaceutical in São Paulo. The tracking system, which must be adopted by all drug manufacturers by December 2016, will permit Anvisa to monitor all drug-related events thanks to a two-dimensional barcode on the product packaging. The code will store information such as batch, expiration date, serial number and Anvisa registration number.

Traceability will also benefit industry by avoiding mistakes, losses and theft: in 2013, 1,964 loads of medications were lost or stolen, and as of September 30, Anvisa has been notified of more than 1,200 loads of stolen or lost medications in 2014.


10/8/14 - UK
NICE recommends TURis system for transurethral resection of the prostate

TransUrethral Resection in saline (TURis, Olympus Medical) is a bipolar electrosurgery system designed for use when surgical intervention is indicated for prostatic enlargement. Currently, for surgical treatment of benign prostatic enlargement, NICE clinical guideline 97 recommends the use of monopolar or bipolar TURP, monopolar transurethral vaporisation of the prostate or holmium laser enucleation of the prostate. NICE’s Medical Technologies Advisory Committee concluded that the evidence demonstrated that the TURis system was of equivalent efficacy to the TURP. It noted the important clinical advantages of TURis are reducing the risk of TUR syndrome that exists with monopolar TURP and in reducing the need for blood transfusion. The Committee considered that it is plausible that TURis will also reduce length of hospital stay and reduce readmissions after surgery, although the evidence on these outcomes was limited.


10/8/14 - India
CDSCO proposes ban on certain plastic drug containers

India’s Central Drugs Standard Control Organization (CDSCO) has proposed to ban Polyethylene Terephthalate (PET) or plastic containers in primary packaging for liquid oral drug formulations for pediatric use, geriatric use and for use in pregnant women and women of reproductive age. The deadline for comments on the proposed ban is 45 days from the date of publication in India’s Official Gazette, and the ban will go into effect 180 days from the date of final publication in the Official Gazette.


10/8/14 - Australia
TGA seeks advice on what to do With NSAIDs

Australia’s Therapeutic Goods Administration (TGA) has opened a consultation on four proposed regulatory alternatives concerning the cardiovascular risks associated with over-the-counter (OTC) non-steroidal anti-inflammatory drugs (NSAIDs). The TGA has concluded that all NSAIDs - celecoxib, etoricoxib, indomethacin, meloxicam, piroxicam, diclofenac, ibuprofen and naproxen - are associated with significantly increased risks of stroke, heart attack and other cardiovascular events. The agency has therefore requested comments by November 6 on the following four options to mitigate the risks:
• Do nothing
• Non-regulatory: Raise awareness and educate health professionals and consumers on the risks associated with the use of NSAIDs
• Regulatory: Invoke labeling changes or reschedule to pharmacist only status
• Combination of the non-regulatory and regulatory


10/3/14 - Brazil
Anvisa clarifies bioavailability studies necessary for approval of fixed dose generics

Brazil’s regulatory agency, Anvisa, has issued a Technical Note clarifying the bioavailability studies needed to demonstrate pharmacokinetic interaction for the marketing approval of a fixed dose generic drug. The agency also republished guidance concerning therapeutic equivalency that was first released on May 17, 2014. The guidance documents are intended to further national policy in support of generic drugs, given the country’s ongoing commitment to reduce the financial burden on the national health insurance system.


10/3/14 - European Union
EMA releases final policy on publication of clinical trials

The European Medicines Agency (EMA) released on October 2 its final policy on the publication of the clinical reports that underpin the decision-making on the marketing of medicinal products for human use. The publicly available data will not contain commercially confidential information, except that in limited cases such information will be published in redacted form.

Although the data is not to be used for commercial purposes, the public will be able to browse or search, download, print and save it. The policy will be implemented as of January 1, 2015 for all clinical reports contained in all applications for centralized marketing authorizations submitted after that date. The reports will be released as soon as a decision on the application has been taken. Access to clinical reports for line extensions and extensions of indications of already approved drugs will begin as of July 1, 2015.


10/3/14 - UK
NICE recommends Lundbeck’s Selincro (nalmefene) for reduction of dependence on alcohol

NICE has released draft guidance recommending Selincro (nalmefene) as an option for people who regularly drink high amounts of alcohol. Selincro is taken as a tablet once a day on an as-needed basis and reduces the urge to drink. The drug is authorized as part of a treatment program including psychosocial support to help people reduce their alcohol consumption. Nearly 600,000 people in the UK will be eligible to receive the treatment.

Commenting on the recommendation, NICE Health Technology Evaluation Centre Director Professor Carole Longson said: “Alcohol dependence is a serious issue for many people. Those who could be prescribed nalmefene have already taken the first big steps by visiting their doctor, engaging with support services and taking part in therapy programmes. We are pleased to be able to recommend the use of namelfene to support people further in their efforts to fight alcohol dependence. When used alongside psychosocial support nalmefene is clinically and cost effective for the NHS compared with psychosocial support alone.”


10/2/14 - US
FDA tackles device cyber security

Device manufacturers should submit plans to the agency for providing patches and updates to the operating systems and medical software used in their devices, according to final guidance issued by FDA on October 1. Moreover, companies should incorporate cybersecurity risks as part of the design and development of a medical device, and submit documentation to the agency about the risks identified and controls in place to mitigate those risks. The FDA’s concerns about cybersecurity vulnerabilities include malware infections on network-connected medical devices or computers, smartphones, and tablets used to access patient data; unsecured or uncontrolled distribution of passwords; failure to provide timely security software updates and patches to medical devices and networks; and security vulnerabilities in off-the-shelf software designed to prevent unauthorized access to the device or network.


9/30/14 - Brazil
Brazil moves toward alternatives to animal testing

Brazil’s National Council for the Control of Animal Experimentation (Concea) has recognized 17 alternatives to the use of animals in research activities, which were published on September 25 (Normative Resolution # 18/2014). Within 5 years, animal testing must be replaced by alternatives in keeping with the ethical principle of the 3Rs, advocated internationally, namely the reduction, refinement and replacement of animal use in tests used to support of documentation required by Brazil’s national regulatory agency, Anvisa. The agency has adopted other measures to encourage and develop alternative methods, such as support for the creation of the Brazilian Centre for the Validation of Alternative Methods - BraCVAM, connected to the National Institute of Quality Control in Health - INCQS-Fiocruz, and participation in the federal government’s National Network of Alternative Methods, Renama.

Also on September 25, Concea opened a consultation on two chapters of the Brazilian Guide to Production and Use of Animals for Teaching Activities and Scientific Research.


9/25/14 - Australia
TGA launches web-based adverse event reporting

Australia’s Therapeutic Goods Administration (TGA) has launched a web-based medicines and vaccine related adverse event (Adverse Drug Reaction or ADR) reporting system for the use of consumers. The new web-based reporting service is one of a range of TGA initiatives targeting consumers that include:
• A consumer brochure outlining what constitutes an adverse event and how to report it
• Awareness activities and messages targeted at consumers
• Consumer research to help plan further activities to raise awareness

According to published research, about 90-95% of medicines-related adverse events globally are not reported to regulatory authorities in large part because there is a low awareness among consumers of available ADR reporting systems. In 2013, only about 3% of ADR reports received by the TGA came from consumers, compared with 55% from pharmaceutical companies, 17% from state and territory health departments, 10% from hospitals and hospital pharmacists and the remainder from community pharmacists and general practitioners.


9/18/14 - Brazil
Anvisa launches drug and device monitoring program

Anvisa has launched two programs for monitoring the quality of medicines and health products in Brazil. The National Program for Quality Control of Medicines (Proveme) will initially analyze monthly samples of drugs from Aqui Tem Farmácia Popular and Farmácia Popular. The Monitoring Project on Health Products Marketed in Brazil will monitor health products available in the market such as orthopedic implants, breast implants and equipment. The information generated under the two projects will be logged in the SGAWeb system, which is also being launched today. SGAWeb allows labs to record samples received, analysis results and analytical reports issued.

The system was first developed in 2011 by the National Institute of Quality Control in Health (INCQS), in partnership with Anvisa. The goal is for the SGAWeb to be used by all of the labs that make up the health surveillance laboratory network, encompassing central, regional, and municipal laboratories, in addition to the provider network.

The agency also launched the Center for Management of Emergency Health Surveillance Information (EVISA). This center is a new unit at Anvisa, which will organize the process of capturing, monitoring and responding to health emergencies. EVISA was inspired by the design of Global Alert and Response (GAR) public health emergency network, consisting of centers set up in various countries and at the World Health Organization (WHO) in Geneva, and gained momentum with the implementation of International Health Regulation.


9/18/14 - UK
NICE urges review of drug evaluation methodology

Following public criticism of its rejection of a number of expensive cancer treatments, the UK’s health cost watchdog is calling for a review of the way new medicines are adopted by the National Health Service. In a statement released today, the National Institute for Health and Care Excellence says it is “positioning itself for a wider role in the way drugs are developed, evaluated and taken up in the NHS”, and wants to involve patients, the NHS, industry and health researchers in a broad debate on access to new medicines.

Earlier this year, NICE published a consultation with proposals on “value-based assessment” intended to give more direction to the independent committees which appraise new technologies on behalf of the institute. The consultation had been demanded by the Department of Health as part of an effort to rein in the £13bn a year spent on pharmaceuticals in the face of rising prices for breakthrough drugs. After consideration of the results of the consultation by NICE’s Board of Directors, however, no consensus was found in responses on the proposed changes.

NICE’s recent statement argues that any changes to its methods need to be made as part of a “wider review of the innovation, evaluation and adoption of new treatments (including those for cancers),” and is proposing a number of changes beyond those to its drug evaluation methodology, including:
• A new office for innovation to help companies navigate through the stages of the development, evaluation and adoption of their products into the NHS
• Agreement between NICE, NHS England and the Department of Health on the NHS's willingness to pay for new treatments, taking into account special cases like ultra-orphan conditions and cancer
• Ways of sharing risk between drugmakers and the NHS, to better reflect the value of new treatments as knowledge about these treatment increases.

NICE chief executive Sir Andrew Dillon, explained that NICE needs to “look at other processes, including the model of pharmaceutical research and development, the expectations that companies and patient groups have about how risk and reward is shared between the industry and a publicly funded NHS, and in the arrangements for commissioning expensive new treatments.”


9/17/14 - Australia
TGA Issues Amended Nonclinical Studies Guidance

Australia’s Therapeutic Goods Administration (TGA) issued on September 15 amended guidance on nonclinical studies for Module 4 of the Common Technical Document (CTD), which is an integral part of an application to register a prescription medicine on the Australian Register of Therapeutic Goods (ARTG). The amended guidance differs from the European Union (EU) guidelines for nonclinical studies, which have been adopted by Australia, by requiring additional information to be included in Module 4, including:
• All relevant nonclinical information, whether favorable or unfavorable to the medicine
• Details of any incomplete or abandoned pharmacological or toxicological testing, as well as individual animal data from toxicity studies, and
• Additional pharmacodynamic and pharmacokinetic studies


9/12/14 - Australia
TGA announces reorganization

Australia’s Therapeutic Goods Administration (TGA) announced an internal reorganization on September 11 that is part of broader structural changes within the Department of Health following the Finance Ministry’s call for a Smaller and More Rational government. The Drug Control Section, which is responsible for administering the regulations on internationally controlled drugs, has moved from the Department of Health’s Office of Chemical Safety (OCS) to the TGA’s Office of Scientific Evaluation. In addition, the Secretariat for the Advisory Committee on Medicines Scheduling (ACMS) has moved to the TGA from the Department of Health.


9/12/14 - EU
EMA issues Q&A on adaptive licensing

The European Medicines Agency released on September 11 a Q&A document on the Adaptive Licensing (AL) pilot project that draws on the experience gained since March from discussions with companies about their drug development plans. The document notes that AL foresees early marketing of a new drug in a restricted patient population, followed by real-world evidence gathering and the likely extension of the marketing authorization to broader patient populations. The guidance also makes clear that a company interested in participating in the pilot must understand that not only EMA, but also representatives from national HTA bodies, organizations that issue clinical treatment guidelines, and patient organizations will be participating in discussions concerning their plans for the AL drug development process.


9/10/14 - India
India’s CDSCO establishes new clinical trial application requirements

India’s Central Drugs Standard Control Organization (CDSCO) issued an order on September 5 with “immediate effect” that all applications for the approval of global and new clinical trials must now include information on the following:
• An assessment as to the risks versus benefit to trial subjects
• Innovation in comparison to existing therapeutic options, and
• Unmet medical need in India

The CDSCO order was sent to “concerned sponsors,” clinical research organizations (CROs), medical institutions, and industry trade associations noting that the requirements have been imposed as a result of an order issued by India’s Supreme Court on October 21, 2013. The Supreme Court order was prompted by a Public Interest Litigation (PIL) petition filed with the Court by the non-governmental organization Swasthya Adhikar Manch (SAM), which sought to halt the conduct of clinical trials in India for new products that would not be sold or marketed in India.


9/10/14 - UK
Celgene’s Abraxane for pancreatic cancer gets thumbs down from NICE

Although Celegene’s Abraxane, in combination with gemcitabine, for previously untreated metastatic pancreatic cancer was shown to extend life expectancy and to have fewer side effects, the UK’s National Institute for Health and Clinical Excellence (NICE), has issued draft guidance not recommending reimbursement by the National Health Service (NHS). The negative decision is based primarily on cost rather than the effectiveness of the drug combination. However, NICE is considering the use of Abraxane in combination with gemcitabine for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.


9/4/14 - Autralia
TGA issues Q&A on drug approval process

Australia’s Therapeutic Goods Administration (TGA) issued a Q&A guidance on September 3 concerning the registration process for a new prescription drug or for making changes to an already registered product that involve clinical, nonclinical or bioequivalence data. The guidance covers a range of questions including a clarification of a consolidated s.31 question that is issued by the TGA for additional information from a sponsor of a marketing approval application. The consolidated s.31 is a single request for information, which brings together in one document all the questions that have been raised concerning the application from all of the relevant review units of the TGA. If a sponsor needs clarification as to any question in the s.31 document, a written request must be submitted to the TGA.


9/4/14 - UK
NICE releases guidance on diagnosis and management of drug allergies

The UK’s National Institute for Health and Care Excellence (NICE) has published a new guideline on the diagnosis and management of drug allergy in adults, children and young people. The guidance recommends that information relating to patients with known or suspected drug allergies should be presented in a structured way, and in should include the generic and proprietary name of the drug(s) suspected to have caused the reaction, including the strength and formulation, and a description of the date, time and symptoms of the reaction.

The guidance recommends that prescriptions should be standardised to record information on which drugs or drug classes to avoid, to reduce the risk of drug allergy, and that clinicians should check with patients about any allergies before prescribing, dispensing or administering any drug.

NICE also recommends a method for prioritising the thorough assessment of any patient suspected of having a drug allergy, and details what signs to look out for. Commenting on the new guideline, NICE Centre for Clinical Practice Director Professor Mark Baker said: “About half a million people admitted into NHS hospitals each year will have a diagnosed drug allergy. If we know that giving someone a particular drug could cause them harm, or in the worst instances may even kill them, the utmost care must be taken to ensure they are not prescribed or administered that drug. This new guideline encourages all healthcare professionals to be alert to the possibility of drug allergies and offers best practice on clinical management to ensure every individual is spared from serious harm.”

NICE gives thumbs up to Alexion's Soliris for atypical hemolytic uremic syndrome
The UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending Alexion's Soliris (eculizumab) for reimbursement by the National Health Service (NHS) for the treatment of atypical hemolytic uremic syndrome, a rare blood disorder that affects around 200 people in England. NICE said the drug is being evaluated under a program looking at highly specialized technologies for people with very rare diseases.

NICE estimates that Soliris will cost the NHS up to £58 million ($95 million) in the first year, increasing to £82 million ($135 million) after five years. The guidance comments that since the budget impact of the product "will be considerable," it recommends that the NHS and Alexion "should consider what opportunities might exist to reduce the overall cost." The draft guidance is open for comment until September 25, 2014.


8/28/14 - UK
£160 Million Increase, 2-Year Extension for UK Cancer Drugs Fund

The UK Department of Health has announced an increase in funding for the Cancer Drugs Fund from 200 million pounds ($332 million) a year to 280 million pounds ($465 million) a year, and extension of the fund confirmed until March 2016. In addition, Two new drugs which will be covered by the fund: Xtandi (enzalutamide) for prostate cancer and Revlimid (lenalidomide) for a new group of patients with myelodysplastic syndrome, a rare blood condition.

Alongside the boost in funding, the Department of Health stated that it will continue to “negotiate with the pharmaceutical industry on cost to ensure best value for the NHS.” Commenting on the funding increase, Health Secretary Jeremy Hunt pointed out that drugs on the list will be continually evaluated, “to ensure patients are offered the most effective drugs for their condition and new drugs can be added to the list, whilst drugs which are the least clinically effective will not be routinely available to new patients.”

NICE recommends Biogen Idec’s Tecidera for multiple sclerosis
The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Biogen Idec's multiple sclerosis drug, dimethyl fumarate (Tecfidera) as a treatment option for adults with relapsing-remitting multiple sclerosis. The drug is only recommended for patients that do not have highly active or rapidly evolving severe relapsing-remitting multiple sclerosis and where the drug is provided at the discounted price agreed in the patient access scheme.

Dimethyl fumarate, which is administered orally, has an advantage over other currently available treatments, all of which have to be injected.

Pursuant to NICE’s decision, the National Health Service must begin paying for the drug within 3 months.


8/28/14 - Brazil
Brazilian Device Industry Prepares for E-submissions

Brazil’s national regulatory agency, Anvisa, told the country’s medical device manufacturers and device trade associations at an August 20 meeting to prepare for e-submissions. The meeting provided an opportunity for the agency to discuss its implementation strategy for the International Medical Device Regulator Forum’s (IMDRF) Regulated Product Submission (RPS) protocol. The protocol is a harmonized electronic submission format for the registration of medical devices, being developed by the countries that make up the IMDRF, such as Australia, Canada, China, the European Union, Japan, Russia and the US. The first step in that process is the Marketing Authorization - Table of Contents (ToC-MA) that defines the new format of the electronic technical dossier.


8/22/14 - Australia
TGA Proposes Major Update of 2001 Labeling Regulations

Australia’s Therapeutic Goods Administration (TGA) is seeking comments on proposals for the first major revision of the 2001 Drug Labeling Regulations, which are intended to address safety risks posed by issues such as:
• Information about the active ingredient(s) contained in the medicine that is not always easy to find
• Use of the same brand name for a range of products with different active ingredients resulting in look-alike medicine branding (this is known as brand extension or trade name extension)
• Medicine names that look alike and sound alike that can lead to use of the incorrect medicine
• Medicine containers and packaging that looks like that of another medicine
• Lack of a standardized format for information included on medicines labels and packaging
• Dispensing stickers that cover up important information

Comments are requested on the options as to revision that are proposed by the TGA in the following documents:
Therapeutic Goods Order (TGO) No 79 - Standard for the labeling of medicines
Comparing TGO 79 with TGO 69
Consultation: Guideline for the labelling of medicines

The closing date for comments is October 7, 2014.


8/21/14 - Brazil
Nanotechnology Committee to establish standards/guidelines

Brazil’s national regulatory agency, Anvisa, has established a multidisciplinary Nanotechnology Committee within the agency with the mandate to develop standards and specific guidelines for the evaluation and regulation of products that use nanotechnology. In addition to the standards and guidance, the Committee must also create a database on nanopartícles or nanomaterials used in health-related products, develop a training plan for Anvisa staff, and address other matters relating to nanotechnolgy. The Committee has a deadline of one year to complete its assigned tasks.


8/21/14 - Canada
Health Canada issues invitation to “ground-breaking” generic pilot

Health Canada’s Therapeutic Products Directorate (TPD) has invited companies to participate in the International Generic Drug Regulators Pilot (IGDRP) program that will use the EU’s Decentralized Procedure (DCP) as an information-sharing model for parallel reviews by participating national agencies of marketing approval applications for generic drugs. Companies have until September 26 to submit to the TPD Expressions of Interest (EOIs) to participate in the program, which offers applicants the potential to obtain marketing approval in several markets as part of a coordinated review process. In addition to the TPD, the other participants in the IGDRF program are the Therapeutic Goods Administration (TGA) of Australia, the Taiwan Food and Drugs Administration (TFDA), and SwissMedic, the Swiss Agency for Therapeutic Products.


8/20/14 - Australia
TGA Opens Review of All Surgical Mesh Devices

Australia’s Therapeutic Goods Administration (TGA) has announced that it will initiate the reassessment of the clinical evidence for each urogynecological surgical mesh implant to determine if each such device complies with the requirements for safety and performance necessary for marketing approval. The reassessment was prompted by the results of the review of the implants by the TGA’s Urogynecological Devices Working Group that found that, while there may be a benefit in certain patients, there is little evidence to support the overall effectiveness of these devices as a product class. Where individual meshes are found to be non-compliant, the agency will initiate regulatory action, such as the cancellation or suspension of the marketing approval for the device.


8/20/14 - Brazil
Biosimilars are Focus of Pre-ICDRA Conference

Prior to the opening of the 16th International Conference of Drug Regulatory Authorities (ICDRA) in Rio de Janeiro, Brazil’s national regulatory agency, Anvisa, will host a pre-conference the central theme of which will be biosimilars regulation. The pre-conference will be held August 24-25 and will be open to industry, academia, non-governmental organizations and other international institutions. The ICDRA conference (August 26-29) will be closed to the public and open only to the participating representatives from regulatory agencies globally, as well as WHO and PAHO. This is the first time that Brazil will be hosting ICDRA, and the agenda for the conference includes discussions concerning good manufacturing practices for pharmaceuticals, risk reduction for blood products, regulation of medical devices, and vaccine and biosimilar production.


8/20/14 - Brazil
Anvisa issues guidance on implementation of track and trace

Brazil’s national regulatory agency, Anvisa, published guidance on August 18 on the implementation of Brazil’s track and trace system for drugs, the National Drug Control System (SNCM). The guidance manual specifies the requirements for mandatory registration with SNCM, the data that should be made available to Anvisa, and the nature of the communication among participants within the pharmaceutical chain of distribution. The manual also defines which events of interest to the track and trace system will be reported to Anvisa.

The manual was the subject of discussion within the Steering Committee for the Implementation of SNCM, which was established by Anvisa for tracking and monitoring the implementation of the national system. The Steering Committee has representation from 25 governmental agencies and other entities.


8/11/14 - India
New Testing Requirements Issued for Blood Glucose Strips

India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on August 7 to all local State Drugs Controllers and port authorities ordering that imports, as well as local manufacture, of blood glucose test strips and analyzer based glucose reagents must provide three batches for testing at the National Institute of Biologicals in Noida. Following the testing, a Performance Evaluation Report must be submitted by the importer or manufacturer with the import application or marketing authorization to the appropriate local authority. CSDCO’s expert advisory committee recommended the new requirements.


8/8/14 - UK
NICE gives thumbs down to Roche’s Kadcyla for breast cancer

The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance confirming its earlier rejection of Roche’s breast cancer drug treatment Kadcyla for National Health Service coverage.

Kadcyla (trastuzumab emtansine) treats women with metastatic HER2-positive breast cancer that cannot be surgically removed and has stopped responding to initial treatment. On average, it extends the life of the patient by six months. About a fifth of breast cancer cases are HER2-positive, and it is thought the drug could benefit 1,500 women a year.

Despite the clear evidence of benefit to patients, NICE took issue with the price of the treatment - at its full price, the drug costs £90,000 per patient. Although Roche agreed to lower the price since the initial rejection in April, NICE concluded that “its high price made it impossible for it to recommend”, and – in uncharacteristically strong language - expressed disappointment in the approach taken by the company: "We are really disappointed that Roche were not able to demonstrate more flexibility,” commented NICE Chief Executive Sir Andrew Dillon. "The company is well aware that we could not have recommended Kadcyla at the price it proposed."


8/6/14 - India
CDSCO issues uniform GMP inspection procedures

India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on August 6 to all local State Drugs Controllers setting forth uniform procedures for conducting drug GMP inspections. Local inspectors are to focus on the GMP requirements for establishing shelf life, validation studies, and ensuring prompt recalls of non-compliance products when necessary. The inspection should last 2-5 days depending on the size and complexity of the manufacturing site, and regulatory action is to be undertaken immediately in those cases where inspection observations have uncovered conditions that could compromise drug quality, safety and efficacy. CDSCO indicates that the report of the inspection findings that prompted regulatory action should be finalized without delay at the end of the inspection.


8/5/14 - Brazil
Anvisa proposes amendments to clinical trial rules

Brazil’s national regulatory agency, Anvisa, announced on August 4 that it has opened consultations on two separate proposed regulations that would amend existing procedures governing clinical trials with both drugs and medical devices. The first, CP 64, targets medical devices, and was prompted by ongoing discussions at the International Medical Device Regulators Forum (IMDRF) on the requirements set forth in ISO 14155/2011, which defines internationally recognized good clinical practice for trials on humans involving medical devices. The second, CP 65, would substantively amend the existing regulation governing clinical trials with pharmaceuticals by having the agency focus on risk management during the conduct of a clinical trial. Anvisa would review a clinical trial protocol and each phase of the trial would first require the agency’s approval before the trial could continue. Interested parties have 30 days to submit comments.


8/5/14 - Japan
Japan’s Prime Minister attends first Brazil/Japan seminar on drugs and devices

The opening of the first bilateral Seminar on the Regulation of Pharmaceutical Products and Medical Equipment, held in Sao Paulo, was attended by the Prime Minister of Japan, Shinzo Abe, and the heads of the regulatory agencies of the two countries, Anvisa’s Dirceu Barbano, and PMDA’s Tatsuya Kondo, on August 2. The national drug and device trade associations from each country also attended the Seminar, such as Brazil’s Association of Manufacturers of High Technology Equipment, Products and Medical Hospital Supplies (Abimed) and Japan’s Federation of Pharmaceutical Manufacturers (JPMA). Topics discussed at the Seminar included ways to enhance bilateral cooperation on each country’s national pharmacopeia as well as expediting the drug and device approval process.


8/4/14 - China
CFDA Issues 5 New Device Regulations

In order to support the implementation of the Medical Device Regulations that came into force on June 1, 2014, the China FDA has issued five new regulations covering:
Medical Device Registration
IVD Registration
Medical Device specification and labeling regulations
Production Supervision and Administration of Medical Devices
Medical Device Regulatory Measures

In its August 1 notice, the CFDA explains that the five new regulations will come into force on October 1 and address:
• Target level of device risk
• Define the scientific approval and filing system for devices
• Specify the information requirements as to device registration as well as production
• Define the main duties and responsibilities of enterprises
• Refine the specification for labeling requirements
• Strengthen regulatory supervision and inspection, and
• Impose strict liability


8/1/14 - India
FDA Advances Personalized Medicine

The U.S. FDA announced on July 31 that it had issued final guidance on the development of so-called in vitro companion diagnostic kits that could be used to identify those patients who would benefit from, or be harmed by, a new drug or a new indication for an already approved drug. The guidance is intended to help companies identify the need for such tests during early drug development and to plan for the development of the companion test in conjunction with the development of the new drug. The guidance also underscores FDA’s intent to have the IVD companion diagnostic device and the drug approved or cleared at or about the same time, for the use indicated in the labeling of both products. According to FDA, the goal of the guidance is to stimulate early collaboration between the IVD device sector and the pharmaceutical industry, as well as the appropriate offices in both CDRH and CDER.


7/30/14 - India
India Proposes eSubmissions for Clinical Trials

India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on July 28 concerning the agency’s proposal to create an Information Technology (IT) system that would permit the online submission of information on clinical trials by sponsors/ clinical research organizations (CROs), investigators, ethics committees, and trial subjects. Information regarding a particular clinical trial entered into the system would generate a Unique Identification Number (UIN) specific to the trial. The trial sponsor would be required to share the UIN with the trial investigators and the responsible ethics committee, and each would be required to provide information into the system on day to day basis. According to the CDSCO, the UIN system would enhance the ability of the agency to monitor clinical trials nationally. The proposal is open for comments for three weeks.


7/25/14 - EU
EMA Concludes Evidence Insufficient That Bodyweight Affects Emergency Contraceptive Effectiveness

The European Medicines Agency has concluded that the evidence that increased body weight lowers the effectiveness of the emergency contraceptives levonorgestrel and ulipristal is insufficient to support inclusion in the product information of statements on the impact of bodyweight. After assessing all available evidence, the agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the deletion of product information that stated levonorgestrel is less effective in women weighing 75 kg or more, and not effective in women weighing more than 80 kg. Although the CHMP noted that there is some evidence that body weight might affect effectiveness, it nevertheless recommended the continued use of these emergency contraceptives by women of all weights, as the benefits of their use outweigh the risks.


7/21/14 - UK
NICE Recommends Wider Use of Atovarstatin

The UK's National Institute for Health and Care Excellence (NICE) issued final revised guidance on July 18 recommending the expanded use of statins, especially atovarstatin. The update to the 2006 guideline on lipid modification recommends that the threshold for starting preventative treatment for cardiovascular disease (CVD) should be cut from a 20 per cent risk of developing CVD over 10 years to a 10 per cent risk. NICE recommends starting statin treatment for primary prevention of CVD with atorvastatin 20 mg, and patients with established CVD, type 1 diabetes or type 2 diabetes, should receive a higher 80mg dose of the drug.

Under the revised guidance, NICE estimates that up to 4.5 million people could be eligible for statins, which could help to prevent up to 28,000 heart attacks and 16,000 strokes each year.

In contrast to the revised NICE guidance, new US guidelines on statins issued in February 2014 by the American College of Cardiology and the American Heart Association recommend that doctors should consider prescribing statins to all patients with at least a 7.5 per cent risk of suffering a heart attack or stroke within the next decade.


7/18/14- Brazil
Brazil’s Anvisa transfers initial patent approval from Director to Superintendent of Drugs and Biologicals

Brazil’s National Health Surveillance Agency, Anvisa, has transferred the initial approval for the award of a patent for pharmaceutical products and processes from the agency’s Director-President to its Superintendent of Drugs and Biologicals (Sumed). The transfer to a subordinate of the Director took effect as of July 17, and does not change the agency’s authority concerning the patent grant process for new drugs and drug processes. According to the Coordinator of Intellectual Property, Antonio Carlos Bezerra, the transfer only involves the recipient within Anvisa of the requests from Brazil’s patent office for the agency’s opinion.


7/18/14- Canada
Health Canada releases 2013/2014 Patent Report

Health Canada has released the 2013/2014 Therapeutic Products Directorate (TPD) report on the administration of the patent and data protection regulations in Canada. The Statistical Report 2013/2014 for the Patented Medicines (Notice of Compliance) Regulations and Data Protection covers trends in the eligibility of patents for listing on Canada’s Patent Register, the eligibility of drugs for listing on the Register of Innovative Drugs, and court activity concerning patent challenges. The Office of Patented Medicines and Liaison (OPML) maintains the Patent Register for new drugs for which market authorizations have been granted by the TPD in the form of a Notice of Compliance.


7/18/14- Spain
AEMPS launches register of manufacturers, importers and distributors of active substances in Spain

The Spanish Agency for Medicines and Health Products (AEMPS) has launched a registry of businesses involved in the manufacture, importation and distribution of pharmaceutical active ingredients in Spain. The Unified Public Business Registry of Active Substance Businesses (RUESA) is part of the transposition of Directive 2011/62/EU, which addresses counterfeit drugs in the European Union and includes additional controls for active ingredients. The aim of the RUESA is to strengthen the guarantees of legal distribution channels and actions against counterfeit medicines, and the registry currently includes data from over 150 companies established in Spain. Companies included in this register must update their information once a year in January and immediately notify AEMPS of any changes that may affect the quality or safety of the active substances manufactured, imported or distributed.


7/18/14- Ireland
Ireland’s HPRA publishes list of 12 active substances safe for Rx to OTC switch

The Health Products Regulatory Authority (HPRA) has published a list of twelve active ingredients (or combinations of ingredients) that are currently classified as prescription-only medicines (POM) which it considers could safely be switched to over the counter (OTC). There are currently 34 drugs approved in Ireland that contain one of the ingredients included on the list, including medicines for the treatment of migraine, acid reflux, hay fever, cold sores, muscle pain and inflammation, fungal skin and nail infections and other inflammatory skin conditions.

Publication of the list was welcomed by the Irish Pharmaceutical Healthcare Association (IPHA), which represents the international research-based pharmaceutical industry in Ireland, and the Irish Pharmacy Union (IPU), which represents 2,100 community pharmacists across the country.

The HPRA is now seeking expressions of interest from the pharmaceutical companies that supply these medicines to apply to have them reclassified.

7/16/14 - India
India’s CDSCO sets up whistleblower reward scheme

India’s Central Drugs Standard Control Organisation (CDSCO) has set up a scheme for providing monetary rewards to informers who provide specific information leading to the seizures of spurious, adulterated, misbranded and not-of-standard-quality drugs, cosmetics and medical devices. This reward scheme will be applicable to both the informers and CDSCO officers involved.

The plan calls for rewards of up to 20% of the value of the products seized, to a maximum of around $41,500 for informants and around $8,300 for CDSCO officials. The reward is to be provided only when the spurious, adulterated and misbranded products are actually seized by CDSCO. In order to ensure the continued cooperation of informants, 25% of the amount is to be awarded at the time of filing of the case in court, another 25% upon a favorable disposition of the case at the first trial level, and the remaining 50% upon final disposition in favor of the government with no appeal pending.

The reward scheme will be overseen by the Drug Controller General, along with other officials. The eligibility of informants and the amount of rewards will be decided by a Committee chaired by the Director General for Health Services, and including representatives from CDSCO, the Customs Department, the Ministry of Health and Family Welfare and social groups/NGOs.


7/14/14 - Brazil
Anvisa proposes alternative Pharmacopeial methods

Brazil’s national regulatory agency, Anvisa, is inviting comments on proposed alternative Pharmacopeial microbiological methods that can be used to replace those currently listed in the Pharmacopoeia, with faster and better results. The proposal complements the framework of documents that are part of the Brazilian Pharmacopoeia, which are important for the domestic production of medicines. The consultation officially opened on July 11 and remains open for 30 days.

Anvisa proposes certification procedures for bioequivalence research centers
Brazil’s national regulatory agency, Anvisa, has opened a consultation on a proposed standard for the certification of research centers in Brazil that conduct bioequivalence and bioavailability studies needed for drug registration in Brazil. The proposed standard would update the existing regulations that mandate the minimum criteria for these studies and for accreditation of the research centers that conduct them. According to Anvisa, the proposed changes to the existing standards are needed to bring Brazil’s regulatory requirements in line with international guidelines that incorporate technical and scientific progress in the field of bioequivalence and bioavailability testing.


7/10/14 - Australia
TGA lifts ban on HIV self-test kits

Following the close on May 6 of a public consultation, Australia’s Therapeutic Goods Administration (TGA) announced that the Secretary of the Department of Health has lifted the ban on the sale of HIV self-tests. The decision is aligned with the Seventh National HIV Strategy (2014-2017), which aims to increase detection of HIV in the community by enabling greater access to HIV self-test kits that have been assessed for quality, safety and performance by the TGA. As a result of the Secretary’s action, tthese kits can now be supplied in Australia, subject to review and approval by the TGA.


7/10/14 - UK
New device holds promise for diagnosing diabetic neuropathy

The UK's National Institute for Health and Care Excellence (NICE) has issued draft medical technology guidance calling for more research on McCallan Medical’s VibraTip, a device intended to diagnose nerve damage caused by diabetes. The draft recommends research on the potential cost benefits to the National Health Service (NHS), including assessing the diagnostic accuracy of the device compared with standard methods of diagnosing the condition. The standard test for loss of sensation in the foot of a diabetic involves checking if a vibration (from a tuning fork) or light pressure (using a 10g monofilament) can be sensed. VibraTip is held against the patient’s foot twice: once while not vibrating and once while vibrating.


7/10/14 - India
Requirements for device clinical trials clarified

By order issued on July 3, India’s Central Drugs Control Organization (CDSCO) has clarified the regulatory requirements that apply to the approval and monitoring of clinical trials conducted with medical devices. According to the Order, although device trials differ from drug trials in that no Phase I trials are conducted, the Ministry of Health has concluded that such trials must adhere to all drug trial requirements, such as accreditation of trial investigators and clearance by ethics committees. The changes implement the recommendations of the Expert Committee chaired by Prof. Chaudhury, which was tasked with formulating policy and guidelines for the approval of clinical trials.


7/9/14 - India
CDSCO clarifies which devices require registration

India’s Central Drugs Standard Control Organisation (CDSCO) has issued an order listing those medical device categories that are subject to the same requirements as drugs under India’s Drugs and Cosmetics Act of 1940.

Under section 3(b)(iv) of the Act, included are “such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.”

The order lists 14 devices categories that fall within that definition, and states that all other devices do not require any registration, license, permission or NOC under the Act for their import, manufacture, sale or distribution in India. The 14 categories are: disposable hypodermic syringes, disposable hypodermic needles, disposable perfusion sets, in vitro diagnostics for HIV, HbsAg and HCV, cardiac stents, drug eluting stents, catheters, intra ocular lenses, I.V. cannulae, bone cements, heart valves, scalp vein sets, orthopedic implants and internal prosthetic replacements.


7/8/14 - Australia
TGA releases amended bioequivalence guidance

Australia’s Therapeutic Goods Administration (TGA) has issued amended bioequivalence guidance applicable to all prescription medicines except for biologicals. The guidance includes European Union guidelines that have been adopted by the TGA, such as: the investigation of bioequivalence, the quality of modified release dosage forms, modified release oral and transdermal dosage forms, and the clinical investigation of the pharmacokinetics of therapeutic proteins. The guidance is intended to assist sponsors of prescription medicines to prepare applications to register new prescription medicines, or vary the registration of an already approved prescription medicine.


7/8/14 - India
CDSCO releases a host of new clinical trial guidelines

India’s Central Drugs Standard Control Organisation (CDSCO) has released a slew of orders making a wide range of changes to the agency’s policies governing clinical trials. New policies stated in the documents include:

• Sponsors, investigators, the regulator and Ethics Committees are responsible for ensuring that the design of placebo-controlled trials is appropriate, efficient and ethical;
• Investigators are limited to working on a maximum of three trials simultaneously;
• If a new chemical entity is approved in the innovator or “well-regulated” country for a disease prevalent in India, and the clinical trial included Indian participants, CDSCO advises that “approval should be sought from CDSCO” and “these NCEs should be marketed in India speedily.” CDSCO also specifies that if a foreign trial included Indian participants, the number would have to be “adequate” for considering approval of the drug in India;
• Waiver of clinical trials in Indian populations with drugs already approved outside India will only be considered in cases of national emergency, extreme urgency and epidemic, and for orphan drugs for rare diseases and drugs for conditions/diseases for which there is no therapy;
• Generics and biosimilars marketing “in other countries like USA” for over four years and have a “satisfactory report” can be approved in India after abbreviated trials;
• Consideration of new drug applications will take into account ethnic differences in metabolism etc.;
• If two or more countries remove a drug from their market on the grounds of safety and efficacy, the continued marketing of the drug in India “will be considered for examination and appropriate action” by CDSCO; and
• Manufacturers, sponsors and CROs are advised to provide compensation for any drug-related anomaly detected at a later stage.

CDSCO is also re-organizing the structure of the committees involved in the drug approval process. The New Drug Advisory Committees will now become the Subject Expert Committees, whose recommendations will be reviewed by a newly formed Technical Review Committee (TRC). The TRC will be under the direction of the Directorate General of Health Services (DGHS), which will draw the membership of the committee from experts in such areas as clinical pharmacology, clinical toxicology/ pathology, and scientists involved in drug development. The changes implement the recommendations of the Expert Committee chaired by Prof. Chaudhury, which was tasked with formulating policy and guidelines for the approval of new drugs, clinical trials, and the banning of drugs.


6/25/14 - China
NW Regional Agencies Sign Anti-Counterfeiting Cooperative Agreement

In order to facilitate anti-counterfeiting enforcement, the five northwest provincial food and drug agencies from Shaanxi, Gansu, Ningxia, Qinghai and Xinjiang signed a regional cooperation agreement on tackling counterfeiting during the Food and Drug Inspection Symposium held in Xi'an, Shaanxi Province on June 20. The agreement covers joint inspections, interagency coordination on enforcement, and a commitment to strengthening the regional food and drug administrative infrastructure. Party members as well as officials from the China FDA attended the signing ceremony.


6/25/14 - EU
Outcome Report on First EMA-EUnetHTA Collaboration Published

The European Medicines Agency (EMA) and the European network for Health Technology Assessment (EUnetHTA) have announced the publication of an article on a joint initiative to enhance the usability of regulators’ reports about scientific assessments of medicines better usable by health technology assessment (HTA) bodies. The article, “Improving the contribution of regulatory assessment reports to health technology assessments – a collaboration between the European Medicines Agency and the European network for Health Technology Assessment”, was authored by EMA and EUnetHTA staff members and published in Value in Health, the Journal of The International Society For Pharmacoeconomics And Outcomes Research.

The EMA-EUnetHTA collaboration - the first joint project between regulators and HTA bodies on a European level - began in February 2010 and was carried out over two years with the goal of improving the contribution European Public Assessment Reports (EPARs) can make to the assessment of relative effectiveness by European HTA bodies. The project assessed changes to the structure and presentation of key information in these EPARs for 10 products over a two-year period to determine if they enhanced the clarity and transparency of the outcome of the scientific-review process in order for HTA bodies to make better informed decisions. As a result, some changes were made to the templates for preparing EPARs and the report concludes that, despite some remaining shortcomings, the quality of documents published by the EMA after authorizing a new drug has improved to better suit the needs of the HTA making national reimbursement decisions.

European Commission Adopts Logo for Legitimate Online Pharmacies
The European Commission has adopted an implementing Regulation under the Falsified Medicinal Products Directive (2011/62/EU) which sets out the design for a common logo for online pharmacies, and the technical requirements for ensuring its authenticity. The logo will appear on the websites of legally operating online pharmacies in the European Union and will link to the national competent authority websites where all legally operating online pharmacies in their respective countries will be listed. The Regulation establishing the new logo should enter into force by the end of July 2014 and Member States have one year to prepare for its application.

The establishment of a logo for online pharmacies is a new milestone in the implementation of the Falsified Medicinal Products Directive. Last year, the EMA upgraded its inspections database so that it contains information on good distribution practice (GDP) in addition to good manufacturing practice (GMP) certificates, and in July 2013, written confirmations from competent authorities outside the EU were introduced to guarantee GMP standards at manufacturing sites for active substances that are imported into the EU.


6/19/14 - UK
Innovative Spine Straightening Device Gets Green Light from NICE

The UK's National Institute for Health and Care Excellence (NICE), has issued final guidance recommending reimbursement for an innovative medical device for straightening the spines of children with scoliosis. According to NICE, the MAGEC system would save the National Health Service (NHS) about $18,000 over the course of treatment per child 2 years and older. The cost savings would come from eliminating the need for the repeated surgery that is now required for the comparator straightening rods. The MAGEC system, once surgically implanted, can be extended without further surgery by using a remote control device that activates a magnet and screw system within the rods.


6/17/14 - UK
NICE Wants More Cost-Effectiveness Data for Gilead’s Sovaldi

The UK's National Institute for Health and Care Excellence (NICE), has requested more cost-effectiveness data from Gilead as to the use of Sovaldi by patients with and without cirrhosis, and with and without HIV-co-infection. The data should be based on the use of sofosbuvir in combination with ribavirin, with or without peginterferon alfa compared with peginterferon alfa and ribavirin in patients with genotype 1 and genotype 3 chronic hepatitis C. NICE issued an interim reimbursement policy in April 2014 assuring access to Sovaldi, used in combination with DAA’s, for patients with Hep C who are at significant risk of death or irreversible damage within the next 12 months, irrespective of genotype.


6/12/14 - Italy
AIFA decides sickest patients to get free Hepatitis C drug

Following an extraordinary meeting of AIFA’s Pricing and Reimbursement Committee on June 9th, the agency has announced that patients with the most urgent cases of Hepatitis C will receive Gilead’s new drug, Sobusfuvir, for free while Gilead and the agency work out an agreement. The drug, which in the U.S. costs between $84,000 and $168,000 a year, eliminates the virus in 90-100% of cases. In a statement on AIFA’s website, the agency said that, pending an agreement with Gilead, "AIFA and Gilead have provided a solution to immediately provide the drug to patients with the most urgent cases of Hepatitis C, or patients with severe recurrence of hepatitis after liver transplantation (fibrosing cholestatic hepatitis or chronic hepatitis with degree of fibrosis) or patients with decompensated cirrhosis on the list for liver transplantation."


6/5/14 - China
CFDA Launches “National Food and Drug Regulation” App

The China FDA (CFDA) has launched a "national food and drug regulation" App that permits the user to directly access the agency’s press releases, departmental rules and regulations, working papers, drug quality announcements, medical device quality bulletins, and drug and device recall information. The App works with iPhone and Android phone operating systems and was developed as part of the government’s commitment to greater public transparency in order to meet the growing public demand for access to food and drug regulatory information. The CFDA notes that a “highlight” of the new App is its search function that permits a variety of queries including queries related to imported drugs and devices.


6/5/14 - India
CDSCO Exempts Certain FDC’s from Safety/Efficacy Requirement

India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on June 5 exempting Fixed Dose Combination products (FDCs) licensed for marketing by State Licensing Authorities prior to September 21, 1988 from the requirement to submit data in support of safety and efficacy. The decision to exempt these FDCs from the scope of the CDSCO’s mandate of January 15, 2013 was based on the fact that the products were licensed before the requirements governing new drugs were included in India’s Drugs and Cosmetics Rules. The decision in practical terms grandfathers such NDCs from the scope of the Drugs and Cosmetics Rules.


6/3/14 - China
CFDA seeks input on draft regulation tightening control of online food and drug sales

The CFDA has released for public opinion a draft regulation that would tighten control of online sales of food and drugs. The rule will drug prohibit producers and wholesalers to sell products to online consumers, and will require sellers of food, health food, cosmetics, and medical apparatus and instruments to obtain permits. The CFDA will crack down on false advertising, and information about certain drugs, including stupefacient, psychotropic substances and radiopharmaceuticals, will not be allowed to be published online. The draft regulation also requires trading platforms to check qualifications of food and drug sellers. The deadline for comments is June 27, 2014.


6/3/14 - Brazil
Anvisa publishes expedited review and approval process for generics

On May 29, Anvisa published a simplified procedure (RDC No. 31) to expedite the registration, post-registration and renewal of registration of generic medicines According to the agency, the new procedure would reduce by approximately 30% the time that it takes for it to review and approve a generic drug marketing approval application. Companies wishing to apply for registration of medicines in accordance with the new regulation may do so exclusively via electronic application, as of June 4, 2014.


6/2/14 - India
India Issues Final Rule for Compensating Clinical Trial Deaths

India’s Central Drugs Standard Control Organization (CDSCO) has released amended rules specifying the formula and the process that will be used for determining the amount of compensation to be paid by clinical trial sponsors for the death of a clinical trial research subject.

Under the amended rules, which took effect on May 30, an Independent Expert Committee will examine the report of the death and make a recommendation within 30 days to the CDSCO as to the amount of compensation to be paid. Criteria to be considered by the Committee include the age of the subject, and the risk factor depending on the severity of the disease, presence of co-morbidity and duration of the disease in the subject at the time of enrollment in the trial.

After the Expert Committee makes its recommendation, the CDSCO will make a final decision on the issue, and will inform the sponsor with three months as to the amount of compensation that must be paid. The sponsor has 30 days from receipt of the CDSCO’s order to pay the amount.





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