Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
CFDA Posts Draft Medical Device Adverse Event Monitoring Guidance
China’s Food and Drug Administration (CFDA) has posted draft guidance on post-marketing supervision of medical devices. The guidance sets out the role regional and national regulators, medical device manufacturers and adverse event monitoring technology institutions will play in tracking the safety of products once they are approved.
CFDA began revising the now eight-year-old policy on adverse event monitoring close to 12 months ago. The 2015 text sought feedback on the proposed addition of a definition for serious adverse events, as well as regulatory reporting requirements and timelines for incidents that fall into the category. CFDA also used the draft to gauge industry responses to plans to subject devices linked frequently to adverse events to more stringent monitoring.
The text released this week retains the previously inserted definition of serious adverse events and many of its implications for medical device manufacturers. CFDA expects manufacturers to start investigating suspected serious adverse events immediately and report the incident to the local monitoring technology agency within 15 days. If a patient has died, the adverse event reporting time falls to five days. Both timelines are unchanged from the 2015 draft.
CFDA has kept similar penalties for failing to comply with these and other reporting requirements, too. Manufacturers charged with poor monitoring and reporting practices or deliberately concealing an adverse event will face fines of between RMB 5,000 and RMB 20,000 ($738 to $2953). The text also gives officials the power to impose RMB 20,000 fines on companies that lack staff responsible for adverse event monitoring or have failed to establish a system to manage the task.
While these cornerstones of the guidance are unchanged from the earlier draft, CFDA has revised the order, wording and intent of the new version in multiple areas. The new draft strengthens the actions manufacturers should take when certain safety situations arise. CFDA now wants manufacturers to immediately stop the production and sale of medical devices in some circumstances, a demand absent from the earlier text. The new draft also opens the door to compensation payments.
CFDA is accepting comments on the text until the end of November.
CFDA Notice, (Chinese)
DCGI Gives FDC Manufacturers More Time to Respond to Show Cause Notices
The Drug Controller General of India (DCGI) has given manufacturers of fixed-dose combination (FDC) products more time to respond to show cause notices. Manufacturers now have 90 days to reply to the notices, three times as long as they were given originally.
DCGI Dr. GN Singh extended the deadline after the matter “was further examined by the Ministry of Health & Family Welfare.” Originally, companies had 30 days to reply. Now, DCGI has reset the deadline at 90 days. The regulator is yet to disclose details of this examination or why it led the ministry to extend the deadline. Whatever the reason, the result is the FDC safety and efficacy saga is set to continue into next year.
The Central Drugs Standard Control Organization (CDSCO) wrote to FDC manufacturers in January 2013 to request data to justify the continued use of their products. The request came in response to a loophole that saw companies bring FDC products to market without DCGI approval. Almost three years later, the safety and efficacy of some FDCs is still unclear.
CDSCO tried to move the process along last month when it sent out show cause notices as part of a batch of close to 1,000 letters to almost 300 FDC manufacturers. CDSCO used the letters to tell manufacturers of the outcomes of the Kokate Committee review into the safety and efficacy of their FDCs. Show cause notices require companies to justify or explain their actions or other matters to the court.
The FDCs of companies that received show cause notices have the most uncertain path forward. The Kokate review granted some manufacturers the right to continue making and selling their FDC products. CDSCO told other firms to run Phase IV trials to show their FDC drugs are safe, effective and, as such, deserve to stay on the market. Whether either of these pathways are open to the recipients of show cause notices will depend on their responses to the letters.
China Establishes Process for Upcoming Radioactive Product License Renewals
CFDA has shared details of the process companies must go through to renew licenses to produce radioactive drugs and diagnostics. Authorities in China introduced the licenses in 2011, and as a result, a surge in applications followed, but now the regulatory permissions of many companies are set to expire.
To help these companies, CFDA has released a document walking them through the renewal process. Each company must file documents including an application form, a good manufacturing practice certificate, a copy of their existing radioactive drug or diagnostic production license and a self-examination report on its premises. The report should detail the nature, known problems and planned improvements of the production and radiation quality management systems.
CFDA plans to follow up on applications with on-site inspections, potentially including spot checks. Companies that fall short of the requirements for radioactive drug and diagnostic production licenses must rectify their failings and undergo another inspection. Authorities will ban manufacturers that are unable to meet the requirements or opt not to renew their licenses from making radioactive products.
The renewal procedure applies to manufacturers of radioactive drugs and diagnostics, but the details of the licenses vary a little depending on the nature of the product. Each license specifies whether it applies to drugs or diagnostics and features other details, such as the dosage form.
CFDA Details Draft Approach to Medical Device Standards
CFDA has detailed a proposed process for revising, implementing and monitoring medical device standards in a draft document. The text gives CFDA responsibility for establishing standards while also encouraging scientific research institutions and other organizations to participate.
A sizable section of the document is given to defining the roles of different organizations. CFDA sits at the top of the tree, giving it responsibility for organizing the formulation of national standards and overseeing their implementation. The task of developing the standards themselves will fall on a medical device standard management center within CFDA. This group is tasked with solving major technical problems, organizing some advocacy and training and other tasks.
The guidance allocates some similar tasks to a technical committee. Chinese authorities foresee the committee helping out with the resolution of problems related to the implementation of standards and running training, advocacy and academic exchanges relevant to international standardization. Regional regulatory units and others are also expected to play supporting roles in the standards process.
The rest of the document covers the workflow that will take standards from the idea stage through to implementation. The establishment of this formal workflow is in keeping with CFDA’s attempts to overhaul the medical device sector in China. In recent years, the regulator has released a steady stream of documents related to different aspects of the medical device market. Collectively, the texts represent a concerted effort to improve how medical devices are developed and made in China.
CFDA Notice (Chinese)
Singh has written to manufacturers to reiterate when his office handles shelf-life extension requests. Letter