Regulatory Focus™ > News Articles > Asia Regulatory Roundup: India Continues Clinical Trial Reform Agenda (6 September 2016)

Asia Regulatory Roundup: India Continues Clinical Trial Reform Agenda (6 September 2016)

Posted 06 September 2016 | By Nick Paul Taylor 

Asia Regulatory Roundup: India Continues Clinical Trial Reform Agenda (6 September 2016)

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

CFDA Posts Draft Guidance on Recalls of Medical Devices

China Food and Drug Administration (CFDA) has released draft guidance on the recall process for medical devices. The text establishes who is responsible for detecting possible defects with medical devices, the process for alerting users of a fault and the penalties CFDA will hand out to companies that fail to meet their responsibilities.

CFDA first adopted regulations covering the recall of medical devices in 2011, at which time the focus was on establishing a system in keeping with international conventions and drug recalls in China. The latest draft lifts large sections from the earlier text. Changes include the relocation of a paragraph on the process for overseas manufacturers from one part of the guidance to another, multiple minor revisions to the wording of the text and the addition of a list of the situations in which a recall may be necessary.

In the 2011 text, CFDA defined defective devices as those that may endanger human health. The revised draft includes this line, too, but also features a broader definition of the type of defects that may force a recall. CFDA is now proposing the recall of devices that fail to meet mandatory technical standards or pose a risk because of quality management shortcomings. The revisions are in keeping with changes to the first paragraph of the text, in which CFDA now includes a more expansive list of reasons for introducing the regulatory document.

CFDA has said little publicly about why it feels the changes are necessary, but the revisions are in line with the evolution of its approach to medical devices in the five years since it introduced the original document. Over that period, and particularly in the past two years, CFDA has published or revised documents about multiple aspects of medical device development, production and supply. The more stringent regulations of quality oversight, adverse event reporting and other topics detailed in these documents are reflected in the changes to the guidance on medical device recalls.

The revised recall document is open for comments until the end of September.

CFDA Notice (Chinese)

Facing Recalcitrant Industry, DCGI Asks Again for FDC Phase IV Protocols 

The Drug Controller General of India (DCGI) GN Singh has written to manufacturers of fixed-dose combination (FDC) drugs to tell them to submit protocols for Phase IV clinical trials. Singh wrote a similar letter in June, but despite that missive following at least 30 months of pressure and requests, some companies still have yet to comply with the demand.

In the latest letter, Singh calls on “all the applicants” who are yet to submit Phase IV protocols to do so, but makes no mention of how many FDC manufacturers have continued to ignore the demand. As of June, “hardly any” companies had filed Phase IV protocols, Singh wrote, but there are reasons to believe the situation may have improved since then. Notably, the June letter followed a decision by the Central Drugs Standard Control Organization (CDSCO) to ban 344 FDCs that it felt lacked safety and efficacy data to support their use.

Singh and CDSCO have been trying to get FDC manufacturers to generate such data by running Phase IV trials since at least the start of 2013, but as the June letter revealed, the vast majority of firms have simply ignored their demands. The publication of another letter by Singh this month shows the regulator is still struggling to compel FDC manufacturers to comply with its request. Singh told FDC manufacturers the latest letter “may be treated as regulatory reminder for further necessary action,” but made no mention of what actions will follow if companies continue to ignore the letters.

Such long-standing recalcitrance among manufacturers has been a recurring theme of regulation in India in recent years. The ongoing attempts to get FDC manufacturers to generate data on the safety and efficacy of their products joins the adoption of a marketing code and implementation of track and trace on the list of areas in which officials have struggled to persuade the industry to comply with their demands.

DCGI Letter

DCGI Lengthens Validity of BA/BE Site Approvals, Continuing Trial Reform Agenda

DCGI has extended the validity of regulatory certifications of bioavailability and bioequivalence (BA/BE) study centers. The change means approvals of the trial sites will now last three years, as opposed to one year under the previous model. 

To benefit from the longer certifications, BA/BE trial sites will have to comply with certain conditions. DCGI expects BA/BE centers to undergo periodic surveillance audits, immediately report all major or critical changes to the center or its systems to CDSCO and submit renewal applications at least four months before the existing approval expires. The regulator is also demanding that audit reports from overseas regulators be shared with CDSCO.

In recent years, overseas regulators have discovered the highest-profile cases of alleged substandard practices at BA/BE testing sites in India. The case of GVK Biosciences, which was chastised by French regulators before ultimately seeing hundreds of products it tested banned in Europe, is perhaps the best known, but not the only, example. Extending the validity of the certifications raises the risk that failings at BA/BE sites will go undetected for longer.

The challenge of striking a balance between mitigating such risks and creating a favorable regulatory environment for research has occupied Indian officials for years. Recently, officials have moved to relax regulations in several areas. The change to BA/BE site certification comes one month after DCGI removed a cap on the number of trials an investigator can run simultaneously, dropped the minimum number of beds a hospital needs to run a study and allowed parallel filing of certain applications.

DCGI Notice

Regional Chinese Regulator Urges Drug Manufacturers to Consider Post-Disaster Planning

Hubei Province Food and Drug Administration (FDA) has released a circular urging manufacturers to consider their post-disaster preparedness plans. The request is intended to ensure drugmakers in the province are able to cope with a flood and quickly bring their operations back online.

Officials at Hubei FDA have asked manufacturers to consider how flooding could affect their ability to produce ingredients and finished products, both in terms of its impact on the availability of water for pharmaceutical use and the functioning of facilities. The regulator is also stepping up its own activities to ensure it is equipped to help manufacturers with the cleanup, disinfection work and other tasks that are needed to recover from flooding.

Publication of the circular on the effects of flooding on drug supply comes two months after Hubei and other provinces were affected badly by extreme weather. The floods in July reportedly killed more than 180 people, forced 1.4 million people to relocate and inflicted severe damage on more than 50,000 houses. The lack of drugs and other medical supplies in the aftermath of such events can worsen the situation.

CFDA Notice (Chinese)

Other News:

The Therapeutic Goods Administration (TGA) of Australia has added more extended-release metformin brands to the list of products in short supply. All of the products tracked by TGA are now classed as having limited availability. The number of brands with this status has increased over the past few months as shortages of some products have increased demand for others. TGA Notice

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