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Posted 27 September 2016 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
CRO Complaints About Online Portal Prompt CDSCO to Convene Meeting
The Deputy Drugs Controller of India (DDCI) has convened a meeting to discuss sponsor and contract research organization (CRO) complaints about the Sugam online portal. Sponsors and CROs made the complaints after encountering problems when trying to use Sugam to apply for regulatory clearances regarding bioavailability (BA) and bioequivalence (BE) studies.
Indian regulators were scheduled to stop accepting hard copy requests for no objection certificates (NOC) regarding BA/BE studies earlier this month, but the transition to the online portal has not gone smoothly. Notably, CROs and sponsors have reported problems with uploading documents to the online portal for the Central Drugs Standard Control Organization (CDSCO). The inability to share files through the Sugam portal could delay the process of obtaining an NOC, diminishing the attractiveness of India as a location for research at a time when the regulator is trying to do the opposite.
In response, DDCI A. Ramkishan scheduled a meeting at short notice. The meeting, which was due to take place last week, was intended to give sponsors and CROs a forum at which to explain the issues they have encountered when using Sugam. As such, Ramkishan asked companies involved in applying for NOCs for BA/BE studies to send a representative well versed in the technical issues affecting the use of Sugam to the meeting. Members of the Centre for Development of Advanced Computing (CDAC) team managing the Sugam project were also due to attend.
The complaints add to evidence that the phased rollout and pre-implementation meetings that have characterized the introduction of Sugam have failed to prevent problems from arising. CDSCO last acknowledged a shortcoming with Sugam in June following complaints that the portal was unprepared for a planned expansion to cover ethics committee registrations and the cosmetic industry. Those complaints prompted Drug Controller General of India (DCGI) Dr. GN Singh to task CDAC with developing Sugam into a “flawless operational platform.”
Now, 10 months after it was introduced, the complaints of sponsors and CROs suggest Sugam is still falling short. The latest meeting was intended to put the CDAC team in a position to address the shortcomings and “streamline the online system for BA/BE NOC.” Such improvements are important given the recent focus at CDSCO on creating a more amenable environment for research, and the spread of Sugam to other regulatory requests, including filings to run clinical trials.
CFDA Opens Draft Medical Device Quality Control Guidelines for Comment
China Food and Drug Administration (CFDA) has released draft guidelines on the quality control and product release of medical devices. The text covers quality matters across the breadth of the supply chain, from the procurement of raw materials through to final inspection rules for finished products.
At each step in the process, CFDA wants manufacturers to adopt policies that cut the risk of a subpar medical device being shipped from their facilities. In the procurement stage, this means putting in place procedures to verify raw materials meet regulatory and technical requirements. The guideline is light on prescriptive details about how manufacturers should achieve this and other objectives, opting instead to refer companies that need more details to documents including ISO 13485.
Details that are communicated in the guideline include the request that manufacturers ensure their sampling activities are statistically significant, be they focused on raw materials, process controls or finished products. CFDA also dictates the minimum information manufacturers must gather at each step of the quality control process. When inspecting finished products, for example, CFDA wants firms to list the name of the device, the acceptance criteria and other types of information.
The publication of the document continues a busy period for the medical device team at CFDA. Over the past few years, CFDA has revised regulations covering multiple aspects of the development, manufacturing and commercialization of medical devices, while also probing the integrity of clinical trial data and outlining plans to introduce a priority approval process. The device initiative is part of a broader drive to raise the standards of medical products sold in China.
CFDA Alert (Chinese)
Chinese Government Agencies Unite to Punish Dishonest Drug Producers
CFDA has united with more than 25 other government agencies for a coordinated crackdown on drug producers that engage in dishonest activities. The initiative is part of the government’s contentious social credit scheme, which aims to monitor the corporate integrity of companies active in China.
By partnering with a range of government departments, including the ministry of finance, the National Health and Family Planning Commission and propaganda unit, CFDA is hoping to give the social credit system some teeth. Now, instead of CFDA being limited to legal actions and industry-specific punishments when dealing with dishonest drug producers, it can draw on the collective power and influence of the government departments involved in the cooperative scheme.
The plan is to use these powers to more forcefully punish wrongdoers. Companies that get on the wrong side of CFDA could be cut off from government financial support and procurement programs. A negative credit score could also cause a company to be subject to more rigorous tax assessments, encounter barriers when applying for customs certificates or suffer many other difficulties intended to punish their behavior.
The signing of the memorandum of understanding between the government agencies and release of details about how they will punish wrongdoers mark another step forward for the social credit system. Details of the system emerged in a government briefing document last year, since when CFDA has teamed up with the Chinese state tax administration to share information on the companies they both regulate.
CFDA Notice, Xinhua (both Chinese)
DCGI Calls Vaccine Manufacturers for Meeting Ahead of WHO Inspections
DCGI Singh has called Indian vaccine manufacturers to a meeting to discuss planned inspections by the World Health Organization (WHO). Representatives of WHO are due to visit India next month to shadow CDSCO inspectors during the assessment of vaccine manufacturing facilities.
A WHO team is due to spend the week starting 17 October in India to assess the performance of inspectors from CDSCO and state licensing authorities (SLA). This will entail going with CDSCO and SLA officials to selected vaccine manufacturing facilities. In preparation, Singh has asked vaccine companies to send a senior manager literate in technical matters and the head of quality assurance to a meeting.
Singh made no mention in the letter of what CDSCO needs to discuss with vaccine producers ahead of the WHO visit. WHO is coming to the country to assess the work of CDSCO and SLAs, not the firms they regulate. The visit forms part of the assessments WHO makes of national regulatory authorities with oversight of vaccine manufacturers. Such assessments conclude with WHO ruling whether the country has a functional vaccine regulatory system.
In 2013, WHO granted this status to India, a decision that had important implications for CDSCO and the vaccine manufacturers it regulates. Without a positive decision from WHO, prequalified Indian vaccine manufacturers would have lost their status, prohibiting them from supplying products to countries through the procuring agencies run by the United Nations. The stakes are similarly high for the upcoming WHO assessment.
Tags: Asia Regulatory Roundup, DCGI, China medical devices, CFDA enforcement
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