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Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China is planning to accept data generated from clinical trials run overseas. The proposal is part of a suite of changes put forward by the State Council to boost China’s support for innovative drugs and devices and accelerate their path to patients.
The State Council broke its proposals up into six sections, each of which contains ideas with major implications for the future of drug and device development and regulation in China. The section on the reform of clinical trials is the largest and potentially most important.
Most notably for multinational drug developers, China is proposing to accept clinical trial data generated overseas, provided the studies comply with relevant requirements. This would free drug developers of the time and expense of running large Chinese clinical trials of products that have already proven their safety and efficacy overseas. The only caveat is companies must cover ethnic differences in their applications.
The rest of the clinical trial reform section covers ways to improve the efficiency and quality of studies run within China. This builds on China Food and Drug Administration (CFDA) proposals to move the country toward a clinical trial approval system reminiscent of that in place in the United States. The State Council’s trial reform package also adds to work by China’s legal and regulatory systems to identify and punish data fraud.
Another section of the State Council notice covers how to speed up the review of applications. The proposals continue China’s work to provide abbreviated development and approval pathways for certain drugs and devices, such as those that treat rare diseases or address other major unmet medical needs.
The State Council is also planning to aid developers of innovative drugs by protecting intellectual property. One idea is to create a patent link system designed to cut the risk of infringements while encouraging the development of generic medicines.
None of the proposals are tied to a timeframe for implementation. Responsibility for turning some of the proposals into functioning initiatives will fall on CFDA, the deputy head of which commented on the reforms during a press conference this week.
Draft Proposals (Chinese), Press Release, Reuters
The Therapeutic Goods Administration (TGA) of Australia has knocked back a request by Pfizer to extend the window for reporting safety issues with biologicals. Pfizer made the request in feedback to TGA’s biovigilance consultation but found TGA is unwilling to shift its position.
The consultation document proposed giving sponsors 48 hours to report serious threats to public health related to biologicals, products based on human cells or tissues or live animal cells, tissues or organs. TGA is proposing to give sponsors 10 calendar days to report serious adverse events linked to such products.
Both timeframes are shorter than those for conventional medicines, the sponsors of which have 72 hours to report serious threats to public health and 15 days to alert authorities to serious adverse events. Pfizer wants TGA to apply these reporting timeframes to biologicals. TGA disagrees.
“The reporting requirements for biologicals described in the guidelines reflect the current existing legislation, and the timeframes are in line with those for medical devices,” TGA wrote in its reply. “We consider this appropriate as a significant proportion of biologicals behave like devices.”
Other respondents, including Novartis, noted the alignment with device vigilance without asking TGA to switch to the medicine timeframes. Novartis did ask for a definition of “sponsor awareness” so it knows when the 48-hour countdown for reporting serious threats to public health starts. TGA complied with this request.
“Day 0 is the day that any of the sponsor's Australian personnel — including sales representatives, investigators or contractors — becomes aware of a significant safety issue or receives the minimum information necessary for adverse event reporting,” TGA wrote.
The agency is aware safety information may go through a global headquarters before being passed on to the Australian office and wants companies to transfer information “without delay.” Failure to do so could result in the 48-hour countdown starting well after an overseas part of an organization learns of a safety issue.
Pfizer Feedback, TGA Response, Novartis Feedback
India has requested applications from manufacturers of certain fixed-dose combinations (FDC) for the third time. The Drug Controller General of India (DCGI) gave companies four months to apply in June but is yet to receive submissions from all affected businesses.
DCGI Dr. GN Singh first called for applications in March. The call was prompted by the identification of FDCs that were classed as rational in the government’s review but lacked the required regulatory clearances. Singh created a pathway for these FDCs. After being alerted to a perceived lack of details in the original notice to disclose the pathway, Singh put out a second memo in June.
The second memo provided a breakdown of the documents FDC manufacturers needed to submit and gave them four months to do so. Companies that failed to meet the deadline would find their FDCs were not considered legally valid.
That threat has failed to mobilize companies. In response to the failure of some companies to file applications, Singh has put out another notice giving businesses two months to send submissions. The latest notice reiterates the threat about the legal validity of the filings, although having let the deadline pass once, it is unclear whether companies will take the ultimatum seriously.
Manufacturers have repeatedly failed to meet deadlines set by Indian regulators. In the case of FDCs, the seven-month struggle to get applications for rational drugs is dwarfed by the multi-year attempt to obtain protocols for Phase IV trials demanded by DCGI.
TGA has issued an 81-page document outlining its incoming procedure for the recall of therapeutic goods. The document is the most radical overhaul of the recall text since the current version was first introduced in 2004.
Officials have made seven sets of revisions to the current text since its introduction, but none have altered its core structure and advice. The new document, version 2.0, makes such changes. The result is a document that more clearly deliniates between immediate and other types of recall and provides companies with walkthroughs for each type of pathway.
TGA has also introduced new types of recall action, product defect corrections and alerts and a new type of non-recall action, quarantine. The agency has also removed some terms found in the earlier text, including recall for product correction and recovery.
Officials felt it was necessary to make these and other changes “in order to ensure it is consistent with current regulatory 'best practice,’” TGA wrote.
The new recall procedure will come into force on 15 January. TGA has released the text ahead of the go-live date to give companies a chance to familiarize themselves with the changes.
TGA Notice, Recall Guidance
TGA has shared the feedback it received on its proposed changes to how unapproved drugs are accessed through its Authorized Prescriber and Special Access Schemes. Most respondents support the big changes proposed by TGA. TGA Notice
Tags: Asia Regulatory Roundup, China accelerated approval, Pfizer, FDC manufacturers