Asia Regulatory Roundup: CFDA to Punish Clinical Trial Data Fraudsters (16 August 2016)

Posted 16 August 2016 By Nick Paul Taylor

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

China Promises to Punish Clinical Trial Fraud, Outlines Vision for Future of Drug Regulation

Chinese regulators are working with the legal system to ensure clinical trial data fraud is punished in the courts. The initiative, which is a near-term priority for officials, forms part of China’s vision for the development of its drug regulatory system between now and 2020.

China Food and Drug Administration (CFDA) detailed its plans for the punishment of clinical trial data fraud in a document about how it plans to adapt its operation to fulfill the government’s vision for the development of the country between 2015 and 2020. The aim is to revise the legal status of fraud in clinical trials by the end of 2016, a timeline that makes it the most pressing judicial priority discussed by the regulator in its 2020 roadmap. CFDA is also working to strengthen punishments for other aspects of pharmaceutical crime, particularly activities that threaten public safety. 

The planned strengthening of punishments is part of a broader strategy to more rigorously monitor the drug industry and work more effectively with law enforcement to ensure wrongdoers are held to account. One aspect of the strategy is the setting of administrative penalties for different discretions, something CFDA is aiming to have in place by the end of 2017. CFDA also wants to improve the ways regulatory information is shared with law enforcement officers with a view to facilitating cooperation between those involved with issuing administrative penalties and their peers in criminal justice.

CFDA covers a multitude of other topics in the long, wide-ranging document. Everything from the development of a dress code for food and drug law enforcement officials to the establishment and expansion of an online review and approval system is covered by the document. Some of the plans presented, such as a move to monitor public opinion online, have not been discussed widely by CFDA in the past. Others are more familiar. Some of the strategies relate to the campaign to improve its workforce, something CFDA plans to achieve by mandating 40 hours or more of training for staff.    

CFDA Release (Chinese)

CFDA Rethinks Media Strategy to Control Narrative in Social Media era

CFDA has outlined how it is adapting its media engagement strategy in response to social media. The article explains how the ability for rumors to spread quickly on social networks has prompted the regulator to share information more widely and rapidly than it did in the past.

In the article, which was published in a government magazine and shared by CFDA on its website, the regulator discusses its response to social media. Bi Jingquan, who took over as CFDA chief last year, described the disclosure of information online as one of the most effective tools for shaping public opinion. With false information, or accurate reports CFDA would rather keep quiet, able to spread very quickly online, Bi’s belief in sharing information to shape narratives has manifested in the active monitoring of social media.

CFDA now has a public information center and website editorial department. These initiatives have contributed to CFDA updating its website more frequently, and on a broader range of topics, than many of its regulatory peers. In parallel, the regulator works closely with state press agency Xinhua and other media organizations to get its messages across, both to readers of news websites, print media and users of social media. CFDA sees users of social media as being particularly susceptible to rumors.

The article cites a video that incorrectly said watermelons were causing deaths through poisoning as an example of how false information can spread, as well as what CFDA is doing to counter rumors. While not discussed in the article, the drug industry faces comparable problems, some of which have been exacerbated by the actions, or inaction, of CFDA. Notably, the scandal about improperly stored vaccines reportedly led some people to question the safety and efficacy of prophylactic injections. Such views can spread quickly and gain legitimacy on social media.

CFDA Notice (Chinese)

CFDA Releases Text on Pharmaceutical Production Processes for Consultation

CFDA has released a document on the pharmaceutical production process for consultation. The text is a precursor to the deadlines by which drug manufacturers must have examined their operations and shared the resulting reports with CFDA, steps that are part of the regulator’s push to raise standards.

Regulators in China expect manufacturers to have carried out the self-examinations of their facilities by the start of October, and have shared a summary of their findings by the start of the following month. The draft document released this week includes a self-inspection summary table CFDA wants companies to use to communicate their findings to its staff. This asks companies to detail the number of production process inconsistencies they discovered, as well as how many affect drug quality. 

What happens once CFDA has the information depends on what the manufacturer found. For firms that found no inconsistencies, business will continue as usual. CFDA is giving manufacturers that find fault with their operations until the end of next year to bring their facilities up to standard and show it they have done so. Companies that fail to hit this deadline for improvement will be told to stop production.

As with many of CFDA’s recent efforts to identify substandard operations, the burden of assessing the operations is on the manufacturers themselves. CFDA is taking steps to ensure companies cannot lie about their findings, though. Specifically, from 1 November, CFDA will task its inspectors with carrying out surprise inspections of facilities. The regulator has not said how many staff it will assign to this task.

CFDA Notice (Chinese)

TGA Expands List of Metformin Brands Affected by Ongoing Supply Shortage

The Therapeutic Goods Administration (TGA) of Australia has added products to its list of extended release metformin brands that are in short supply. TGA first confirmed the shortage in June, since when supply constraints in some areas of the market have affected the availability of other brands.

TGA has labeled three more brands of 500 mg metformin as having limited availability. Some of the brands are those that were mentioned as alternatives to products in short supply when the situation first arose earlier this year. Similar cascading effects have occurred throughout the duration of the shortage, which TGA characterized originally as being the consequences of constraints at some suppliers leading to surges in demand for other products that the market was unable to meet.

The upshot of these developments is that TGA now lists six metformin products as being in short supply. Two products, both of which are extended-release 1000 mg formulations from Alphapharm, are listed by TGA as being available. These formulations were listed by TGA earlier this year as being unaffected by the supply shortages as batches were released in April. At that time, TGA thought Alphapharm would have its 500 mg formulations on the market by the end of May.

However, both of Alphapharm’s 500 mg formulations are listed as having limited availability in the latest update. Extended-release 500 mg products manufactured by Apotex and Arrow Pharma are also listed as having limited availability. The Apotex products, which are branded as being from Terry White Chemists and Chemmart, are new additions to the list of products with limited availability. TGA has provided no guidance on when it expects the supply shortage to end. 

TGA Alert

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Categories: Biologics and biotechnology, Drugs, Crisis management, Due Diligence, Regulatory strategy, Regulatory intelligence, News, Asia, Oceania, CFDA, TGA

Tags: Asia Regulatory Roundup, clinical trial fraud, metformin, drug manufacturing

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