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4/23/14 - UK
Life-extending Breast Cancer Drug Gets Thumbs Down

The National Institute for Health and Care Excellence (NICE), the UK’s cost containment agency, has issued a preliminary recommendation against reimbursement for Roche’s innovative breast cancer treatment, Kadcyla, even though the drug extends life by 6 months. NICE concluded that the cost of the drug outweighed the life extending benefit, but added that it is prepared to reconsider the negative decision if Roche were to reconsider and lower the price of the drug. The deadline for Roche to reconsider is May 19, 2014, the official close of the public comment period on the draft reimbursement recommendation.


4/17/14 - UK
Burn Healing Spray Gets Reimbursement Delay

The UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending more clinical and cost-effectiveness studies for the ReCell Spray-On Skin system, an innovative new product for healing burns. According to NICE, the agency’s medical technology evaluation process looks at whether a new device when compared with similar products offers equal benefits at lower cost, or increased benefits at the same cost. The ReCell procedure is performed entirely on site at bedside, takes approximately 25 min to complete and does not require laboratory facilities, off-site culture of tissues or specialized staff. NICE’s head of health technology evaluation stated, “It's essential to note that this draft recommendation for further research doesn't mean that this promising device should not be used … it's important that more data can be generated to help inform further considerations on its clinical utility.”


4/16/14 - UK
Six Erythropoiesis-Stimulating Agents Get Green Light from NICE

The UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending six erythropoiesis-stimulating agents (ESAs) that boost red blood cell production in cancer patients undergoing chemotherapy. The six ESAs – Amgen’s Aranesp, Hospira’s Retacrit, Janssen-Cilag’s Eprex, Roche’s NeoRecormon, and Sandoz’s Binocrit - were found to be “clinically effective and value for money” by improving anemia and reducing the need for regular blood transfusions. NICE also recommends use of the ESA with the lowest cost to the National Health Service (NHS).


4/14/14 - Brazil
Anvisa Expedites Device Imports

Brazil’s national regulatory agency, Anvisa, has expedited the process for importing high-risk medical devices (Class III and IV) by agreeing to initiate the review of such devices pending the grant of the Certificate of Good Manufacturing Practices (CBPF) for the foreign manufacturing site. According to Anvisa, under the revised procedure (RDC 15/2014), new high tech devices should enter the Brazilian market sooner, since the analysis of the device by the agency can proceed while the manufacturing site awaits CBPF certification. Moreover, lower risk devices, such as gloves, syringes and some surgical instruments, will no longer require CBPF certification prior to import, which will eliminate about 25% of the CBPF certification applications received by the agency.


4/14/14 - China
CFDA Targets Counterfeit Internet Sales

At the April 8 China FDA (CFDA) and provincial agencies teleconference on Internet advertising enforcement, CFDA Vice Minister Liu Peizhi called for strengthening joint supervision and joint law enforcement between the national and provincial agencies. He pointed out that currently there are 600 million Internet users in China and that 68% of the world's counterfeit drugs are sold through the Internet. China’s food and drug regulatory authorities have grasped the nature of radio, television, newspapers, traditional media advertising, he said, but now must study the characteristics of the new media and how to find and prosecute illegal advertising and sales of drugs, medical devices, health food and non-pharmaceutical drugs on the Internet.


4/11/14 - EU
EU Moves to Bulk Purchasing of Vaccines and Drugs

The European Commission announced on April 10 that it had approved a joint procurement mechanism that would permit the bulk purchase by EU member states of vaccines and drugs in times of “a cross border health threat.” The Joint Procurement Agreement stems from concerns raised by member states about the purchase of medicines during the 2009 H1N1 influenza pandemic. The Agreement outlines the practical arrangements that govern the procurement procedure; defines the decision-making process with regard to the choice of procedure; and organizes the assessment of tenders and award of the procurement contract.

The Commission also noted the potential for the Agreement to be extended to cover the purchase of drugs for other infectious diseases, such as botulism, anthrax, hepatitis B or polio.

So far 27 countries have declared that they intend to sign the Agreement, which will take effect two weeks after the Commission and a third of the member states (10 countries) actually sign it.


4/9/14 - EU
EMA Set to Finalize Clinical Trials Transparency Policy

The European Medicines Agency (EMA) announced on April 8 that it plans to launch a final round of meetings in May with organizations representing patients, academia, the pharmaceutical industry, and European Union (EU) institutions before finalizing its clinical trials transparency policy. The intent is to merely “fine tune” specific aspects of the policy, such as the possible redaction of the clinical study reports for those parts of clinical trial data that exceptionally contain commercially confidential information. The agency also plans to clarify how it will communicate with the sponsors before any disclosure of their data, as well as how the data will be made publicly accessible.

The agency specifically clarified that it is “committed to pursuing the objective of full transparency regarding clinical trial data because it believes that the release of data contributes to establishing trust and confidence in the system.” The EMA intends to present the final form of the policy to its Management Board for approval in June 2014.


4/9/14 - UK
Blood Clot Detection/Management Devices Get Preliminary Green Light

The UK cost containment agency, NICE, has issued draft guidance recommending two viscoelastometric testing devices - the ROTEM system (TEM International) and the TEG system (Haemonetics) - to help detect, manage and monitor blood clotting (haemostasis) during and after cardiac surgery. The agency’s Diagnostics Evaluation Committee found that the use of viscoelastometric devices is associated with less mortality, a reduced probability of experiencing complications, less need for transfusion and lower hospitalization costs. Haemostasis is the complex process by which the blood clots in order to prevent blood loss following an injury to a blood vessel. Viscoelastometric point-of-care testing helps guide the clinician to select the most appropriate treatment to stop bleeding, thus preventing blood clotting, and is mainly used in adults having major surgery associated with high blood loss, such as cardiac surgery.


4/8/14 - EU/Autralia
EMA and TGA to Share Orphan Assessment Reports

The European Medicines Agency (EMA) and Australia’s Therapeutic Goods Administration (TGA) have agreed to expand their existing regulatory cooperation arrangement to include the sharing of full orphan drug assessment reports. The decision was taken on April 4 at a meeting in London between EMA’s Executive Director Rasi and TGA’s National Manager Skerritt. Under the terms of the agreement, both agencies could engage in a scientific exchange in order to facilitate the evaluation of an orphan drug application that is submitted to both the TGA and EMA at the same time. However, both agencies have reserved the right to reach their own decisions locally as to marketing approval. The EMA and TGA also exchange information in a number of other regulatory areas, such as mutual recognition of good manufacturing practices (GMPs) for medicines.


4/7/14 - EU
EU communication highlights importance of pharma cost-effectiveness

On April 4, the European Commission issued a Communication to Member States on how to achieve “effective, accessible and resilient health systems” highlighting “the cost-effective use” of pharmaceuticals and health technology assessment (HTA) as key to achieving those objectives. Acknowledging that “the EU needs a competitive pharmaceutical industry,” the Commission directs Member states to “reflect further on how to reconcile the policy objectives of ensuring accessible healthcare for all EU citizens with the need for cost containment.” The Commission also advises taking care to “minimize any unintended effects that current national pricing systems may have in terms of accessibility throughout the EU.”

The Commission’s Communication also underscores the importance of health technology assessment for improving access to innovative technologies and supporting efficient allocation of funds. The Commission states its support for the current HTA network (EUnetHTA), recommending the re-use on a national level of the information it develops in order to avoid duplication of effort. In addition, the Commission plans to collaborate with the HTA network to develop a “more ambitious and stable structure to support scientific cooperation on HTA.”


4/7/14 - Canada
Health Canada overhauls product monograph guidance

Health Canada issued revised product monograph guidance on April 4 that not only sets forth new design and format requirements, but also includes a new section on preparing patient information. According to Health Canada, the changes are intended to emphasize clinical relevance, make information easier to retrieve and provide format and information consistency across different drugs and drug classes. The revisions also include specific guidance for the following drug groups: a product that has been granted a notice of compliance with conditions; a subsequent entry (bioequivalent) product; a Schedule C (radiopharmaceutical) product; and a Schedule D (biological) product. Product monographs provide information for the safe and effective use of a new drug and also set the standard for drug promotion and advertising.


4/4/14 - EU
European parliament clears clinical trials transparency directive

European Union lawmakers voted 594-17 on April 2 in favor of new rules requiring the disclosure of clinical trial data, and simplifying the process for getting clinical studies started. The Regulation approved by the European Parliament is expected to take effect in 2016 and will require publication of the results of all new clinical trials within a year of the trial ending. Pressure for greater transparency of clinical trial results has been building following a number of highly publicized drug safety issues. The new rules provide for publication of “detailed summaries” of clinical trial result to a publicly accessible database, which will allow independent researchers to verify whether particular drugs are as safe and effective as they are claimed to be.

In addition to making clinical trial data publicly available, the new law will also simplify the trial approval process, with a single portal for submitting applications, more efficient assessment procedure, and facilitation of cross-border trials through harmonization of requirements among EU member states. According to EU Health Commissioner Tonio Borg, the new rules should save research institutions and companies conducting clinical trials in the EU some 800 million euros ($1.10 billion) a year in regulatory costs.


4/4/14 - Brazil
Anvisa changes GMP requirements for certain devices

On March 31, Brazil passed legislation to ease the registration process for certain low-risk medical devices. Under the new law, Class I and II devices registered with Anvisa and included in the agency’s IN 2/2011 exception list are exempt from GMP certification and fee requirements. In addition, registrants of higher risk Class III and IV devices will now be able submit market authorization applications while GMP certification is still pending, rather than having to wait until they obtain final certification.


4/2/14 - Brazil
Innovative Drugs in Brazil Get Lowest Price Increase in 5 Years

The Brazilian Board of Adjustment of the Drug Market (CMED), which sets annual caps on price increases for pharmaceuticals, set the price increase cap for innovative products as of March 31 at 1.02% or a level that is 5.5 times less than the rate of annual inflation. In contrast, generic drug products were allowed price increases up to 5.86% or more than 5 times that of innovative medicines, which are grouped in the “less competitive” product category that accounts for about 40% of the Brazilian pharmaceuticals market. The average allowable price increase was 3.35%, one of the lowest authorized for the regulated market of drugs in the last five years and below the level of annual inflation.


4/2/14 - China
CFDA Announces Major Overhaul of Device Regulation

The China Food and Drug Administration and the State Council Legislative Affairs Office announced newly revised medical device regulations at a joint news conference on March 31 in Beijing. The revised regulations that go into effect as of June 1, 2014 establish a regulatory system based on the degree of risk posed by a device, from low to high, divided into three risk classes. The low risk product class will be subject to records management, while the moderate to high risk device will be subject to premarket review and approval. Moreover, device-manufacturing enterprises will be responsible for product quality control and safety management of the devices, which includes the establishment of a purchase and sale recordkeeping system. The amended regulations are the endproduct of six years of effort, and represent the first major overhaul of the system of device regulation since its inception in April of 2000.


3/31/14 - Autralia
TGA proposes warnings for OTC oral cough medicines and nasal decongestants

Australia’s Therapeutic Goods Administration (TGA) has released for comment proposed new labeling warnings for OTC cough medicines for oral use related to use by children. The changes to the so-called Required Advisory Statements for Medicine Labels (RASML) follow the recommendations made in 2012 by the TGA cough and cold review concerning products that contain the following ingredients: ammonium salts, bromhexine, dextromethorphan, dihydrocodeine, guaifenesin, ipecacuanha, pholcodine, or senega and ammonia.

The TGA is also proposing new labeling warnings for OTC nasal decongestant medicines for topical use related to use by children. The changes to the RASML follow 2012 TGA cough and cold review recommendations concerning products that contain oxymetazoline or xylometazoline. The proposed new decongestant labeling would also address the issue of rebound congestion by requiring a new advisory statement to the effect that "Frequent or prolonged use may cause nasal congestion to recur or worsen."

The deadline for comments on both proposals is April 25, 2014.


3/31/14 - Brazil
Brazil requiring a year’s notice before drug withdrawal

Drug manufacturers must now provide a year's notice to Brazil’s national regulator, Anvisa, prior to withdrawing a drug from the market if that withdrawal might lead to a shortage of the drug. The objective of the new mandate approved on March 25 is to allow the necessary measures to be taken in advance of the withdrawal, in order to reduce the potential impact on the patient population for which the drug is indicated. The 12-month notice mandate also covers situations where the intent is merely to reduce the level of production or importation of a drug, rather than total marketing withdrawal. Where the withdrawal or production reduction would not pose a risk of a shortage, the mandatory notice can be made six months ahead rather than twelve. There is a 72-hour notice requirement if sudden previously unforeseen circumstances could lead to a drug shortage.

Anvisa releases 2013-2014 regulatory priorities report
The report on the 2013-2014 regulatory priorities for Brazil’s Anvisa was released on March 26 at a tribute in Brasilia in observance of the agency’s 15th anniversary. The key regulatory priorities identified in the report for the agency are post-registration monitoring, good manufacturing practices enforcement and implementation of the national waste management program, which includes drug disposal. According to the agency’s Coordinator for Strengthening Institutional Capacity for Management in Regulation (Pro-Reg), Jadir Day, the regulation priorities demonstrate alignment with “the best practices of international regulation."


3/31/14 - India
CDSCO specifies data format for unapproved FDCs

India’s Central Drugs Standards Control Organization (CDSCO) has issued a notice to state drugs agencies specifying the format for the safety and efficacy data that manufacturers of unapproved Fixed Dose Combination (FDC) drugs must submit to the agency, no later than July 15, 2014. This is the fifth notice sent to local drugs agencies on this matter since January 2013, but the first to set forth the format for the data that must be submitted to support continued marketing of unapproved FDCs. India’s drug associations (IPA, IDMA, OPPI, and SPICS) were copied on the notice.


3/28/14 - Brazil
Nanotechnology Under Microscope in Brazil

The Board of Brazil’s national regulatory agency, Anvisa, was cautioned by the agency staff about the need to carefully evaluate whether and to what extent nanotechnology should be subjected to regulations. Anvisa’s Director of Monitoring and Control, Jaime Oliveira, told the Board that a cautionary approach is needed because nanotechnology is a cutting edge new technology that holds great promise for the development of new drugs and health products. On the other hand, the coordinator of the Anvisa’s Committee for Nanotechnology, Peter Binsfeld, added that because it is a new technology, there is also the need to gauge its impact on health.


3/28/14 - UK
Chair of MHRA Leaving

Sir Gordon Duff, the chairman of the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced on March 27 that he is giving up his position at the agency after his recent appointment as Principal of St Hilda’s College, Oxford. The move is to take place “later this year” and the Department of Health has already initiated a recruitment process to find a successor for Sir Gordon. Prior to taking the position as chair of the MHRA in January 2013, Sir Gordon had been Chair of the Commission of Human Medicines (CHM) and Chair of the Scientific Pandemic Influenza Committee.

Changes to NICE HTA Appraisal Process Proposed
The UK’s National Institute for Health and Care Excellence (NICE) opened a consultation on March 26 on proposed changes to the way it makes recommendations on reimbursement of new health technologies (medicines, medical devices and other technologies) by the National Health Service (NHS). The changes include adding two new criteria for value-based assessment when considering a new technology, namely burden of illness and wider societal impact. Burden of illness is the loss (or shortfall) in quality and length of life, measured in QALYs (quality adjusted life years), which occurs as a consequence of having a disease or condition. ‘Wider societal impact’ is the loss (or shortfall) in a person’s capacity to engage with society as a result of living with the disease or condition, compared with their capacity to engage with society without the condition. The deadline for comments is June 19, 2014.


3/27/14 - Brazil
Brazil Announces Final Deadline for Drug Disposal Plan

Brazil’s Ministry of Environment (MMA) has issued a final deadline of April 6 for the pharmaceutical industry to submit a proposed plan for implementing the sectoral agreement to ensure the environmentally sound disposal of medicines and their packaging after use by consumers. The sectoral agreement requires the implementation by industry of the mandated drug disposal measures within five years in all cities with more than 100,000 inhabitants. This is the third deadline set by the government for industry to submit an implementation plan for the agreement that it participated in developing with the government working group that was coordinated by Anvisa.


3/27/14 - UK
Roche’s MabThera Gets Thumbs Up from NICE

The UK’s National Institute for Health and Care Excellence (NICE) issued final guidance on March 26 recommending reimbursement for Roche’s MabThera, a new treatment for the rare autoimmune disease anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. What makes this decision somewhat unique is that the positive reimbursement recommendation was not conditioned on Roche lowering the price of the drug through a so-called patient access scheme for the National Health Service. Apparently the decision turned on the fact that MabThera is an innovative new treatment that provides a needed option for patients for whom further treatment with the standard therapy, cyclophosphamide, would exceed the maximum cumulative dose allowed for that drug.


3/25/14 - UK
Sanofi’s Colorectal Cancer Drug Gets Final Thumbs Down from NICE

The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance recommending against reimbursement for Sanofi’s colorectal cancer drug, Zaltrap. Although the drug extends life by almost 2 months, NICE concluded that it was not cost-effective, even with the company’s proposed discount. Sanofi’s appeal of an earlier negative final guidance filed in January of this year was rejected on all points by NICE, primarily because of the cost-effectiveness issue.


3/19/14 - Brazil
Brazil Looking for Enhanced Role in Multi-Country Clinical Trials

At a hearing on enhancing pharmaceutical research in Brazil, the chair of the Senate Social Affairs Committee, Senator Waldemir Moka, called for the creation of a working group of government agencies and academic researchers who would prepare proposals on ways to bring multi-country clinical trials to Brazil. Another Senator, Ana Amelia, noted the possible need to revise the existing legal framework governing the conduct of clinical trials in the country, if necessary. In response, the CEO of Anvisa, Dirceu Barbano, noted that it is important to improve the timeframes for the approval of clinical trials, but that that it is also important to ensure the rights and safety of clinical trial subjects. Barbano added that the issue of enhancing Brazil as a site for clinical trials would be discussed this year, as part of the agency’s Regulatory Agenda for 2013/2014.


9/19/14 - China
Abbott and Teleflex Recall Devices

In a March 18 notice to the provinces and municipalities, the China FDA (CFDA) announced the voluntary recall by Abbott Trading of its Freestyle blood glucose meter, which used with Freestyle Lite glucose test strips, might produce erroneous hypoglycemia results. In a separate notice the same day, the CFDA also announced the voluntary recall by Ireland’s Teleflex Medical Devices of it double-lumen endobronchial intubation device because it may cause lung isolation failure. The CFDA also instructed local authorities to enhance regulatory supervision of medical devices.


3/16/14 - China
Q&A Clarifies New Device Crackdown

China’s FDA issued a Q&A document to the provinces and municipalities on March 15 designed to clarify the purpose of the notice that it sent on March 13 on the new national Special Action Program calling on local authorities to crack down on illegal activities relating to medical devices, especially device registration, production, distribution and use. The Program will run through August 15, 2014, and will focus on the prosecution of companies involved in illegal activities, and will include ordering the cessation of marketing as well as mandatory recalls of defective devices nationwide. A primary focus of the crackdown will be the registration of class II and III medical devices, especially clinical trial reports submitted by first time registration submissions for Class III devices.


3/16/14 - India
CDSCO Sets Out Role of Its International Unit

India’s Central Drugs Standard Control Organization (CDSCO) has posted the organizational structure and functions of its International Cell, which interfaces with foreign governments and regulatory agencies – and investigates reports of quality concerns with India drug exports. Among its other functions, the Cell focuses on bilateral Memoranda of Understanding (MOUs), grants written confirmations for API exports from India to the European Union, and hosts visits by foreign delegations. The CDSCO notes that the Cell hosted the visit of Dr. Hamburg, the Commissioner of the US FDA, on February 10 this year and lists the members of FDA’s delegation that included Lou Valdez, FDA’s Associate Commissioner for International programs.


3/6/14 - India
CDSCO Moves to Expedite Investigation of Quality of Drug Exports

India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on March 5 to all state drug regulators that reports concerning the quality of drug exports referred for investigation are to be treated as top priority matters. A preliminary report of such an investigation must be submitted to the CDSCO within 15 days, and a completed report within 3 months. The purpose, according to the notice, is to permit the information to be “flashed to embassies and government agencies of those countries” in a timely manner, to help in “allaying doubts and misinformation about the quality of drugs exported from India.”


3/5/14 - UK
NICE Reverses on Pfizer’s Kidney Cancer Drug

The National Institute for Health and Care Excellence (NICE) has reversed an earlier decision and now in new draft guidance recommends reimbursement for Pfizer’s new kidney cancer drug, Inlyta. The key factors for the reversal are that Pfizer agreed to discount the drug and that the drug “almost met the end-of-life criteria” because it was shown to be a life-extending, end-of-life treatment for this form of cancer. Pfizer appealed the initial rejection of reimbursement of the drug and the appeal body ordered NICE to reopen the assessment process, especially as to how Pfizer’s drug compared to other medications for kidney cancer.

Alexion Asked to Justify Price for aHUS Drug
The National Institute for Health and Care Excellence (NICE) has asked Alexion Pharma UK to justify the allegedly “high cost” of its drug Soliris for treating atypical Haemolytic Uraemic Syndrome (aHUS). This is the first cost-effectiveness assessment that NICE has conducted under its new Highly Specialized Technologies program. Under the new program, NICE only considers drugs for very rare conditions that are either new drugs in development (20 months prior to marketing authorization) or new indications for already marketed drugs (15 months prior to marketing authorization). aHUS is a chronic condition that causes severe inflammation of blood vessels and the formation of blood clots in small blood vessels throughout the body, affecting about 200 people in the UK.


2/26/14 - Russia
Russian Device Trial Sites Now Require Prior Authorization

Russia’s Federal Service on Surveillance in Healthcare (Roszdravnadzor) has issued a reminder notice to all medical device trial sites that as of February 25 they must first obtain the approval of the agency before conducting trials at their facilities. The agency added that it will post on its website a list of the names of the facilities that have obtained the agency’s approval to conduct clinical trials with devices. The pre-clearance requirement stems from an order issued by the Ministry of Health in May 2013, which established the criteria and the procedures for obtaining Roszdravnadzor’s approval.


2/26/14 - UK
NICE Gives Bayer’s Eylea for Macular Edema Final Green Light

The UK’s National Institute for Health and Care Excellence (NICE) has cleared Bayer’s macular edema drug Eylea for reimbursement by the National Health Service (NHS) in final guidance issued on February 26. Bayer has agreed to provide the NHS with a significant discount in the price of the product, which combined with clinical head-to-head studies with the established therapy (ranibizumab), facilitated the final decision to reimburse the drug. The reimbursement decision does not cover Scotland, where NICE’s counterpart, the Scottish Medicines Consortium, has not as yet reached a decision as to reimbursement for Bayer’s drug.


2/25/14 - China
CFDA Issues Regulatory IT Standards

China’s FDA announced 10 information technology (IT) standards on February 24 that are designed to promote the interoperability of the country’s food and drug regulatory information system. The IT standards cover food and drug classification and coding, regulatory infrastructure information such as agency personnel, data sharing and exchange interface specifications, a common regulatory support platform and a drug regulatory software development process specification. There will be a gradual transition to the new standards based on actual experience gained during their implementation.


2/25/14 - UK
NICE Gives Preliminary Go-Ahead to Janssen-Cilag’s Invokana for Type 2 Diabetes

The UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance that recommends National Health Service reimbursement for Invokana (canagliflozin), Janssen-Cilag’s new drug for Type 2 diabetes. Invokana is a sodium glucose co-transporter (SGLT-2) inhibitor that works by blocking the reabsorption of glucose in the kidneys, which is instead passed out of the body in the urine. The drug has received a European marketing authorization for treating type 2 diabetes in adults aged 18 years and older to improve glycemic control.

In 2011, it was estimated that there were approximately 2.6 million people over the age of 17 in the UK with Type 2 Diabetes, and that the real figure could be considerably higher, since many cases go unreported.

The draft guidance is open for comment until March 17, 2014.


2/19/14 - Australia
Joint implant companies warned by TGA

Australia’s Therapeutic Goods Administration (TGA) warned hip, knee and shoulder implant companies that they will no longer be able to market their products after June 30, 2014, unless they submit reclassification applications for their devices before that date. Joint implant devices are being reclassified from Class IIb (medium risk devices) to Class III (high risk devices) as of July 1, 2014, and the TGA gave companies a two-year grace period to file reclassification applications in order to ensure that their products could remain on the market. Each company that received the January 28 letter from the TGA found in the letter a list of their devices that the TGA has targeted for marketing cancellation, unless the agency receives reclassification application in a timely manner.


2/13/14 - China
Device law amendments clear State Council

China’s State Council Executive Committee cleared a Revised Medical Devices Bill on February 12, 2014, that modernizes China’s current device law, which was implemented more than a decade ago. The new changes include adjustments to the definition of medical devices and device classification rules; additional measures for monitoring the quality of medical device production and risk monitoring; new medical device adverse event monitoring, including traceability and recall systems; and increased penalties for violations of the law and regulations. The process to revamp medical device regulation began in 2006 under the former State Food and Drug Administration, which submitted the proposed revisions in 2008 to the State Council Legislative Affairs Office for its review and further modification.


2/13/14 - Russia
Russia implements approval requirements for healthcare entities conducting medical device trials

Russia’s Ministry of Health has issued an order establishing a requirement that medical organizations obtain approval before conducting clinical trials on medical devices, and setting forth the procedure for ensuring compliance.

According to the order, before undertaking a clinical trial, a medical organization must submit an application to Russia’s Federal Service on Surveillance in Healthcare, Roszdravnadzor, together with a host of required documents. Information to be submitted includes the entity’s address and contact info, license for medical practice indicating the medical activities involved in the medical device testing to be conducted; the entity’s charter; information on its intensive care unit, if the trial involves a high risk device; measures for ensuring protection of confidential information; information on bed space, structure, staffing and history of regulatory compliance.


2/11/14 - China
Expedited Review Process for Innovative Devices Announced

The China Food and Drug Administration (CFDA) announced on February 7 the implementation of an expedited new priority review and approval process for innovative medical devices, to take effect as of March 1, 2014. The CFDA stressed that the expedited procedure would not lower existing review and approval standards, but instead would expedite the marketing of new innovative medical device technologies. The procedure is expected to promote the research and development of innovative new medical device technologies. In order to qualify for the new review process, a medical device must have a patent or a patent pending, and provide a significant clinical benefit.


2/6/14 - India
CDSCO Reminds Fixed Dose Combination Manufacturers of Deadline

India’s Central Drugs Standards Control Organization (CDSCO) issued a notice to state drugs agencies on February 3 to remind local companies marketing Fixed Dose Combination (FDC) drugs not approved by the agency that the deadline to submit safety and efficacy data is approaching. The CDSCO deadline expires on July 15 of this year, after companies were given 18 months to submit the data by notice of January 15, 2013. The CDSCO added in its recent notice that it has established 10 expert committees to review data submitted in order to assess the “rationality’ of such fixed dose combinations as well as their safety and efficacy – and that it has received many applications.


2/5/14 - Brazil
Anvisa study reveals benzodiazepine pricing variations of up to 680%

A survey by Brazil’s National Health Surveillance Agency (ANVISA) shows differences of up to 680% in the price of benzodiazepines, a class of drugs used to treat anxiety disorders. The study analyzed the amounts charged in 2013 for 14 drugs with 7 different modes of activity. Prices ranged from R $ 5.92 to R $ 34.62. In comparing products with the same active ingredient, the product with the least variation in price was Clobazam, with a variation of 20%, and the product with the highest variation was Alprazolam, at 348%.

Benzodiazepines are recommended as second-line treatment of anxiety disorders because of the uncertainty of their long-term efficacy, the potential for abuse and their addictiveness, among other reasons. Nevertheless, benzodiazepines top the list of the five highest selling prescription drugs in Brazil.


2/4/14 - Brazil
Anvisa holds hearing on creation of traceability steering committee
Anvisa’s proposal for the creation of a management committee for the consolidation of the National Drug Control System (SNCM), better known as Traceability, was debated at a public hearing held at the agency’s headquarters on January 23. Anvisa’s proposal recommends the creation of an interdisciplinary and intersectoral committee that would be composed of about 21 members from industry, academia, and the government – and would be coordinated by Anvisa. The main issue raised by participants at the hearing was the need to ensure that the management committee members would be fully representative of all segments of society that are involved in drug Traceability. At the conclusion of the hearing, Anvisa CEO Dirceu Barbano noted that he hopes that the management committee will at some point propose measures to expand the system in the future, to extend traceability to the end consumer.


2/4/14 - India
CDSCO issues guidance on LVP manufacturing certification
India’s Central Drugs Standard Control Organization (CDSCO) has issued guidance to applicants requesting approval for the manufacture of large volume parenteral products (LVP). In order to obtain LVP manufacturing certification, the applicant’s manufacturing premises must comply with Schedule M Good Manufacturing Practices (GMPs). The CDSCO also recommends that a company not submit an application for a license until the manufacturing facility is ready with respect “to most of the licensing requirements” because failure to do so will impede a final inspection and may delay re-inspection. Moreover, the applicant should have all the required documentation in place during an inspection.


1/30/14 - Brazil
Brazil launches new adverse event reporting system

Brazil today is launching an online system for health professionals to report serious or fatal accidents involving defective products or services. Health professionals will log adverse events involving drugs, toys, cosmetics and food into a new Consumer Accidents Information System (SIAC), initially on a voluntary basis, but eventually reporting will be mandatory. The Municipal Hospital of Cuiabá was chosen to test the system, although any healthcare professional can post reports on the website,

The Ministry of Health plans courses to encourage adherence to the reporting requirement, and says that the process will be similar to the one currently used in hospitals to identify occurrences of violence against women. "We do not want to create another obligation,” said Juliana Pereira, head of the National Bureau of Consumer Protection (Senacon), a department linked to the Ministry of Justice. “We hope to find new partners to expand oversight of unsafe products in Brazil, which are responsible for a lot of public and private healthcare expense in this country."

Health care providers will enter into the new system the patient’s personal data, the product or service that caused the problem and the procedures adopted. There are specific fields to enter the brand, product model and supplier, but this information is not mandatory, because many times consumers themselves don’t remember it. The data will be analyzed by the Ministry of Justice and the National Health Surveillance Agency (Anvisa) in order to evaluate the need for government action. The Ministry of Justice does not intend to make the reports public, unless government action is needed.


1/29/14 - China
Hospira, Covidien, American Philips Medical Systems devices recalled

The China FDA (CFDA) issued notices on January 14 to the provinces and municipalities announcing the voluntary recall of devices produced by three U.S. companies: Hospira, Covidien, and American Philips Medical Systems. The information concerning the defective devices was reported to the CFDA by the Shanghai Food and Drug Administration. The recall of Hospira’s infusion pump was prompted by problems with the pressure sensor calibration offset; Covidien’s recall of its ventilator was prompted by a software error; and, the Philips Medical Systems’ computed tomography recall was also prompted by a software error.


1/29/14 - UK
Device for scoliosis gets preliminary green light

The UK National Institute for Health and Care Excellence (NICE) has opened a consultation on draft guidance supporting the reimbursement for Ellipse Technology Inc.'s MAGEC system, a device that straightens and lengthens the spine of children aged 2-11 with scoliosis. The device offers savings to the National Health Service (NHS) by avoiding the repeated surgery – twice a year - in children with conventional implanted “growth” rods. Once implanted, the MAGEC rods can be extended without surgery, using a remote control device to activate a magnet and screw system that sits within the rod. The company estimates that the use of the device would save the NHS around $3,000 per patient annually over a 6-year period, compared with using conventional growth rods. An estimated 90 children a year in England require the use of surgically implanted rods to correct scoliosis.


1/23/14 - UK
NICE supports Sanofi’s Aubagio for MS in final guidance

The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance recommending that Aubagio® (teriflunomide 14 mg) be reimbursed by the National Health Service (NHS) for the treatment of adults with active relapsing remitting multiple sclerosis (RRMS), a chronic, disabling, neurological condition. Aubagio is the first oral, once-daily, first-line therapy to significantly reduce annualized relapse rates and the risk of disability accumulation compared to placebo in Phase III controlled trials and will provide an alternative to injectable first-line treatment options.

Teriflunomide is a selective immunomodulatory therapy with anti-inflammatory properties, and is the first product in Genzyme's pipeline of MS therapies to receive final NICE recommendation and become available to patients in the UK. Approximately 100,000 people in the UK have MS, with about 2,500 newly diagnosed with it each year. Eighty-five percent of MS patients are initially diagnosed with RRMS.

NICE’s final guidance ensures that Aubagio will be reimbursed by the NHS within 3 months. Teriflunomide was approved by the European Medicines Agency in August 2013, and NICE gave it a provisional thumbs-up in December after asking Genzyme for additional information on its effectiveness. It is the second MS treatment to be recommended for NHS reimbursement after NICE backed Novartis' Gilenya (fingolimod) in April 2012.


1/20/14 - Australia
Interim Assessment Evidence Acceptable for Joint Reclassification

Due to the fact that Australian companies are having difficulty in obtaining examination evidence from European notified bodies, Australia’s Therapeutic Goods Administration (TGA) announced on January 17 that it will accept summary technical reports as interim evidence to support applications for reclassification of partial hip, knee and shoulder implants from Class IIb to Class III. The summary technical reports must demonstrate that the European notified body properly assessed the device and is of the view that the device meets all the relevant Essential Principles of the Therapeutic Goods (Medical Devices) Regulations.

In order to take advantage of this exception, a company whose device was assessed by a European notified body as a Class IIb device must submit a reclassification application to the TGA in time for the agency to receive the application before June 30, 2014. Moreover, a company that submits its application in a timely manner - and the TGA decides the device can remain on the market - will be required to submit a design examination application within the following 12 months. The TGA developed the interim solution in conjunction with the Medical Technology Association of Australia (MTAA).


1/16/14 - Brazil
Similar drugs in Brazil to have same status as generics

Brasilian Health Minister Alexandre Padilha and Anvisa Director Dirceu Barbano have announced a public consultation on new rules that will grant similar medicines the same status as generics. The move will allow pharmacists to provide consumers a similar drug as a substitute to the branded product. This option, called interchangeability, is currently allowed only for generics. The difference between similars and generics is that the former possess a trade or brand name, while the latter have only the generic name of the active ingredient. Brazil currently has 185 manufacturers of similar products, representing some 43% of the market, while generics and branded products respectively account for 27% and 21% of market share.

The change in a product’s classification will be preceded by a price review by the Chamber for Drug Market Regulation (Cmed). Generic drugs currently cannot cost more than 65% of the cost of the reference product. Currently, adjustment of the price of similar products is made according to a formula established by Cmed, and the review does not necessarily lead to a linear reduction in their price. With the new scheme, the Ministry of Health hopes to reduce the price of similar drugs, which, like generics, will be required to be priced 35% lower than the reference products.

The change in policy also reflects a 2003 decision by Anvisa setting the end of this year as a deadline for similar medicines to submit bioequivalent testing for agency approval, a requirement that has always existed for generics. Following approval, similar drugs will be called "equivalent" medications and their packaging will bear a yellow band with the "EQ" symbol, like generic medicines. "The symbol will help consumers and doctors to know that the product has proof of equivalence and have the exactly same therapeutic function as reference drugs," explained the director of Anvisa.

The expectation of the Ministry of Health is that by the end of 2014, all similar drugs will be technically equal to the reference products. "We are extending the same quality standards that have been established for generics. From the end of 2014, no similar product without equivalence testing may be marketed in the country," said Health Minister Alexandre Padilha. According to data from Anvisa, virtually all manufacturers of similar products are already in compliance with the requirement.


1/13/14 - India
India’s Commerce Secretary Says Country’s Imports Targeted by Foreign Governments

India’s Drugs Consultative Committee has released a report of its November meeting, with recommendations under the 12th Five-Year Plan for strengthening the country’s drug regulatory infrastructure at both the central government and state levels. Noting that India is the third largest producer of drugs by volume (with a value of $28 billion) and exports about half of its production to more than 200 countries, the emphasis of the meeting was on enhancing the country’s international reputation, and ensuring that its drug industry is not compromised by reports of substandard products.

Joint Secretary of India’s Ministry of Commerce & Industry Shri Sudhanshu Pandey claimed at the meeting that drug imports from India – particularly generics – are being targeted by a number of countries in an attempt to protect their domestic pharmaceutical industries, and stressed that it is India’s responsibility to ensure the reputation of its pharma industry on the international market. To this end, provisions for enhancing the regulatory infrastructure include increasing manpower, stepping up training of regulatory officials, enhancing testing facilities, requiring states to upgrade their regulatory systems, and requiring CDSCO to inspect at least one clinical trial site every month. The Ministry of Health and Family Welfare’s Shri R. K. Jain also urged representatives from state regulatory agencies as well as the CDSCO to be present during the inspection of a local Indian manufacturing unit or a clinical trial site by agencies of the European Union and the US FDA.


1/13/14 - Turkey
Turkey Announces Conditions for Issuance of Medical Device Free Sales Certificates

Turkey’s Pharmaceutical and Medical Device National Databank, TITUBB, posted an announcement on its website on January 7 concerning the issuance of Free Sales Certificates for medical devices intended for export from Turkey. According to the announcement, the Certificates will only be available for devices that comply with the EU Directives covering Medical Devices, Active Implantable Devices, and In Vitro Diagnostic Devices. The application form for obtaining a Certificate has been posted on the agency website and is available for download. The announcement also sets out the fee structure for such Certificates and the method for payment of the fee.

Silver-coated Devices in Turkey Will Require EC Certificate of Conformity
Turkey’s Pharmaceutical and Medical Device National Databank, TITUBB, issued a notice on January 10 that as of June 30, 2014, medical devices with anti-bacterial silver coating will be only accepted for registration in Turkey when accompanied with an EC Certificate of Conformity. The decision follows the issuance by the EU in June 2013 of a clarification concerning the classification of such devices as Class III, which requires the devices to comply with conformity assessment procedures. The EU clarification applies to devices where the silver coating is intended to serve as an anti-microbial agent.


1/10/14 - India
India’s CDSCO Issues Guidance on Recording Informed Consent

India’s Central Drugs Standard Control Organization (CDSCO) issued guidance on January 9 on how to conduct audio-visual recordings of the informed consent process conducted with prospective clinical trial subjects. The guidance implements an order issued by the CDSCO on November 19, 2013 requiring the audio-visual recording of informed consent for subjects of all domestic and global clinical trials.

The guidance specifies that information about the research and the nature of the prospective subject’s participation must be provided both verbally and in writing, and must be in non-technical, understandable language. The document also sets out requirements for the process, quality, storage and archiving of the audio-visual recording, and specifies that all documents must be preserved in compliance with principles of confidentiality. The guidance also requires that oral consent be obtained from the subject for the informed consent recording process itself, and states that there should not be any restriction on the trial subject’s right to ask any questions related to the study because any such restriction would undermine the validity of informed consent.

The audiovisual recording requirement follows the recent tightening of the regulation of clinical trials following a 2012 parliamentary report that found that 33 new drugs were approved by the CDSCO between January 2008 and October 2010 without any clinical studies at all.


1/9/14 - India
India’s CDSCO Clarifies that Bioequivalence Testing Centers Require Drugs Controller Approval

India’s Central Drugs Standard Control Organization (CDSCO) issued a “clarification” to local authorities that laboratories intending to engage in bioequivalence and bioavailability (BA/BE) testing must first obtain the approval of the CDSCO before engaging in such activities. In the clarification, the CDSCO notes that BA/BE study results will only be recognized if they are conducted by such approved facilities. Moreover, the same approval requirement extends to facilities that conduct studies on behalf of laboratories that lack the capacity to conduct either a BA or BE study themselves.

Earlier this year, the Prof. Ranjit Roy Chaudhury expert committee formed by India’s Health Ministry to formulate new drug approval policy, recommended that BA and BE studies on patients should be done as part of the clinical trials of all new substances and generics introduced in India. Subsequent generics of the same drug, however, showing good absorption orally and similar in vitro release rate need not undergo BA and BE studies, according to the committee.


1/2/14 - China
CFDA Clarifies Sterile GMP Compliance Deadline

According to a bulletin issued by the China FDA on December 31, 2013, manufacturers of blood products, vaccines and injectable drugs that have not obtained certification of compliance with the revised (2010) good manufacturing practices (GMP) may not market those products as of January 1, 2014. Companies with facilities that have passed GMP inspection prior to January 1, 2014, may continue to manufacture products, but those products may not be marketed until after the actual certificate of GMP compliance has been issued. All other manufacturers must first apply for and obtain GMP certification before engaging in the production of these products.


1/2/14 - UK
NICE draft guidance recommends Ferring Pharmaceuticals’ Firmagon for prostate cancer

The National Institute for Health and Care Excellence (NICE) has issued new draft guidance recommending degarelix (Firmagon, Ferring Pharmaceuticals), as an option for treating advanced prostate cancer in people with spinal metastases who are at risk of impending spinal cord compression. Degarelix is a hormone therapy drug that is used to treat advanced prostate cancer. Over 37,000 men are diagnosed with prostate cancer every year in England and Wales. NICE has already recommended a number of treatments for the disease including abiraterone, and enzalutamide.

Consultees, including the manufacturer, healthcare professionals and members of the public can now comment on the preliminary recommendations which are available for public consultation.

NICE give thumbs up to Cell Therapeutics’ Pixuvri in final draft guidance
The National Institute for Health and Care Excellence has issued final draft guidance given the green light to Cell Therapeutics’ Pixuvri (pixantrone) to treat certain people with aggressive non-Hodgkin's B-cell lymphoma, a disease which starts in the body’s B cells, and affects the lymphatic system. The guidance only recommends the treatment for people with this type of cancer whose disease has either returned after treatment (relapsed) or become resistant to current therapy (refractory) and (1) have previously been treated with the drug rituximab (MabThera) and (2) are receiving third or fourth line treatment.

The guidance also says that the drug can only be funded if the manufacturer provides it at a discounted rate, as agreed between Cell Therapeutics and the Department of Health.

Consultees have until January 23, 2014 to appeal against the draft recommendation if they believe there are sufficient grounds to do so. If no appeals are lodged, publication of the final guidance is expected in February.

NICE opens consultation on Centocor’s Stelara for psoriatic arthritis
The National Institute for Health and Care Excellence (NICE) has opened a consultation on draft guidance that recommends against National Health Service use of Centocor’s Stelara (ustekinumab) for the treatment of active psoriatic arthritis. Psoriatic arthritis affects the joints and connective tissue, and is associated with psoriasis of the skin or nails. It is a progressive disorder, ranging from mild synovitis (inflammation of the tissue lining joints such as the hip or shoulder) to severe progressive erosion of the joints.

The Independent Appraisal Committee evaluated the clinical and cost effectiveness of using ustekinumab alone or in combination with methotrexate, for treating active psoriatic arthritis in adults when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “NICE currently recommends golimumab, adalimumab, etanercept and infliximab for treating active and progressive psoriatic arthritis in adults (technology appraisal guidance 220 and 199). The Committee accepted that ustekinumab is clinically effective compared with conventional DMARD treatment, but the Committee was not persuaded that ustekinumab provides clinical benefits compared with TNF alpha inhibitors. The Committee also noted that the economic analyses found that ustekinumab was not a cost effective option.”

The consultation is open until January 17, 2014.

NICE final draft guidance gives green light to Bayer’s Eylea for macular edema
The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending Bayer’s Eylea (aflibercept solution for injection) as an option for treating visual impairment caused by macular oedema secondary to central retinal vein occlusion (CRVO), where the vein to the retina is blocked. NICE is recommending that the treatment only be prescribed if the manufacturer makes it available to the National Health Service under terms agreed with the Department of Health as part of a patient access scheme.

The independent Committee decided that an appraisal consultation document (ACD) was not needed for this appraisal, so the recommendations could go straight to a final appraisal determination (FAD). This happens when the Committee recommends a treatment in line with its licensed indication. Consultees now have the opportunity to appeal against the draft recommendations. Final guidance is expected to be published in February 2014.




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