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Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The China Food and Drug Administration (CFDA) has released a provisional document regarding the validation of clinical trial data. Under the model, CFDA’s audit team will conduct on-site assessments of the records kept by clinical trials to verify the authenticity and integrity of data purporting to show the safety and efficacy of medical interventions.
CFDA plans to detail its intention to conduct an on-site clinical trial inspection on its website before the scheduled visit. This publication provides the applicant with a 10-day window in which to withdraw its filing and, in doing so, negate the need for an inspection by CFDA. In giving applicants this recall window, CFDA is providing a get-out route to companies that know their data will not stand up to regulatory scrutiny. CFDA gave companies a similar option when it initiated the self-audit program for clinical trial data last year.
The proposed verification measures are a continuation of the thinking behind the self-audit agenda, which gave CFDA a way to filter out applications based on dubious data from its backlog of filings. Under the proposed model, any applicant that opts against withdrawing its filing will have its records inspected by CFDA staffers, who are tasked with looking for evidence of problems with the quality of the data. Within 10 days of completing an on-site inspection, the verification team will review its findings and communicate its opinions to the principal investigator.
Officials at the CFDA drug evaluation center will also learn of the findings. This is when the failure to withdraw a filing that is based on incomplete or fraudulent data can start to have consequences for a company. The drug evaluation team will factor in any shortcomings in the data when making its decision on a product, potentially leading to the rejection of applications that are reliant on data of questionable veracity. Perhaps more seriously, the discovery of such data by the on-site inspectors can lead to fraud investigations.
If the measures work as intended, the chances of products coming to market in China on the basis of questionable data should diminish. This has been a problem in the past. As The Wall Street Journal reported this week, under the leadership of Zheng Xiaoyu, CFDA approved 150,000 drug applications. The execution of Zheng in 2007 amid accusations of bribery was part of an attempt to stop the approval of subpar drugs. Yet the spate of filing withdrawals that followed the initiation of CFDA’s self-audit program suggested many firms were still trying to win approval on the basis of suspect data.
CFDA Procedures (Chinese), WSJ
The National Human Rights Commission (NHRC) has called for the Indian government to comment on media reports regarding reassurances it is alleged to have made about compulsory licenses. If the reports are true, NHRC thinks the government may be cutting the Indian public off from cheaper medicines.
NHRC, an autonomous public body responsible for protecting human rights, became interested in the topic following the publication of articles in the Indian media last month. The articles quoted the US-India Business Council (USIBC), a lobby group that claimed to have been “privately reassured” by the government regarding the likelihood of India overriding drug patents. Such actions, which are known as compulsory licensing, are an ongoing source of tension between public health advocates and the drug industry.
For its part, NHRC thinks the government has a responsibility to do what it can to make medicines available to more of the population. “Providing an affordable healthcare system is a basic bounden duty of any Government,” NHRC wrote in a statement outlining its request to the government. After reading the media reports that the government is opposed to invoking compulsory licenses outside of a public health emergency, NHRC has asked the Indian ministries of commerce and health to provide reports regarding the allegations within the next two weeks.
The context of recent rulings has increased NHRC’s interest in the topic. Specifically, NHRC has linked reports of government reassurances to recent decisions regarding compulsory license applications. “It is a matter of concern that two applications for grant of compulsory license to manufacture generic medicines for treatment of diabetes and cancer were rejected last year,” the public body wrote. If the rejections are linked to a shift in policy regarding compulsory licensing, NHRC would see the government as having impinged on the rights of Indian citizens to access healthcare.
NHRC Statement
The Drugs Controller General of India (DCGI) has proposed measures to ensure clinical trial and drug approval applications are dealt with within the allotted timeframes. DCGI wants applications that require evaluation by subject expert committees to be processed within three weeks.
Hitting this target would help India bring some consistency to the timelines for its approval process, the variability of which have historically been a source of frustration for the industry. To achieve this goal, DCGI is planning to eliminate some of the back and forth communication that can characterize the process.
Specifically, when an applicant has replied three times without addressing a query the regulator raised at the start of the communication, DCGI wants officials to forward the matter to his office. The measure should limit the risk of resources being tied up in repetitive communication that fails to address the underlying issue with an application.
Similarly, when prescreening the first and second replies an applicant provides to a query, DCGI is advising officials to assess whether the respondent evaluated the query before sending their reply. The relevant division of the Central Drugs Standard Control Organization (CDSCO) is tasked with assessing the content of replies in conjunction with the subject expert committee, when applicable.
DCGI Letter
The Food Safety and Standards Authority of India (FSSAI) is temporarily limiting the scope of its regulatory enforcement of the nutraceuticals sector. FSSAI has taken the measure while it awaits the adoption of the incoming Food Safety and Standards Regulation, a draft copy of which was released last year.
Until the text is finalized and comes into force, FSSAI has agreed to limit its enforcement activities to the testing of nutraceuticals, food supplements and health supplements that came to market after the introduction of the Food Safety and Standards Act in 2011. Nutraceuticals awaiting approval as of 19 August, the date on which a Supreme Court order prompted FSSAI to withdraw its approval process, are also exempt. FSSAI is also limiting enforcement of products that are explicitly covered under the draft notification on nutraceuticals, food supplements and health supplements.
The action prompted mixed reaction among members of the industry interviewed by Indian media. Talking to the Press Trust of India, Piruz Khambatta, Confederation of Indian Industry chairman of the National Committee on Food Processing Industry, welcomed the order, which he sees as addressing the operational issues of the industry. In contrast, RK Sanghvi, head of the nutraceuticals committee of the Indian Drugs Manufacturers' Association, told The Economic Times: “We cannot rely on drafts for enforcement. This is like the ban on fixed-dose combinations all over again.”
FSSAI Notice, PTI, The Economic Times
Tags: Asia Regulatory Roundup, clinical trial data integrity, compulsory licenses, FSSAI