Asia Regulatory Roundup: CFDA Looks to Resolve Vaccine Shortages (12 July 2016)

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

CFDA Calls on Regional Regulators to Work to Resolve Vaccine Shortages

The China Food and Drug Administration (CFDA) has called on its regional offices to take steps to resolve the country’s vaccine supply shortage. The request comes at a time when CFDA and the vaccine industry it regulates are adapting to the changes that were proposed in response to the scandal that recently engulfed the sector.

CFDA sees the implementation of the revised vaccine distribution and procurement regulations as a way to address the shortages. The regulator is encouraging staff at all levels of its organization to both adopt the aspects of regulations that are relevant to their jobs and encourage manufacturers and distributors to bring their practices in line with the new policies. Officials have created the new regulations to end the conditions that allowed organizations to supply improperly stored vaccines for years.

The enforcement of the new regulations is seen as preventing such illegal activities and supporting the supply of safe, effective vaccines. In its notice calling for staff to work toward this goal, CFDA also mentioned some other actions it wants its offices to take. Specifically, CFDA wants its staff to step up their supervision, inspection and product sampling activities. CFDA’s ambitions for such work extend beyond the identification of noncompliant organizations. The regulator also sees the actions as an opportunity for regulators to work with the vaccine industry to raise standards.

CFDA wants its staff to actively help companies to solve the problems they identify. In doing so, the regulator thinks it can help the industry achieve sustained and stable output of vaccines. Specific areas in which CFDA wants to see its staff provide regulatory support include the construction of cold chain logistics networks. Such work will serve two purposes: The presence of a functioning cold chain could lead to the elimination of improperly stored vaccines from the supply chain, while also helping to ensure that logistics capacity constraints never restrict the availability of products.

The regulator also used the notice to address issues outside its traditional areas of focus. Officials are concerned the storage scandal has affected consumer confidence in the safety and efficacy of vaccines. As such, CFDA is encouraging its staff to work to raise awareness about the importance of vaccinations. The regulator is also urging manufacturers to do their part. CFDA wants companies to establish and stick to production schedules, even if temporary sales difficulties tempt them to cut or stop output.  

CFDA Notice (Chinese)

China Steps up Oversight of Botox Following Adverse Event Reports

CFDA is intensifying its oversight of Botox in response to reports of adverse events. The regulator is calling for its staff to cut the risk of such events by stepping up their activities across the supply chain, from oversight of companies that manufacture Botox to scrutiny of the clinics that administer the drug.

China is going through a surge in demand for cosmetic medical interventions such as Botox. In this environment, there are opportunities for unscrupulous producers, distributors and clinics. Faced with this situation and reports that people have experienced adverse events after being treated with Botox, CFDA has set out how it wants its staff to regulate the market. The first step in the strategy is to ensure that the Botox produced in China meets quality standards. To advance this objective, CFDA is asking its staff to increase oversight of producers and ensure they follow the toxic drugs guidance.

While these actions should encourage legitimate manufacturers to comply with guidance, they are unlikely to stop counterfeiters. CFDA is looking further along the supply chain to stop fakes. The regulator wants its staff to ensure players in the Botox supply chain keep the necessary paperwork. By auditing these paper trails and identifying companies that have failed to maintain them, CFDA is hoping it can uncover organizations that are involved in the illegal supply of Botox. Alongside this work, CFDA is trying to ensure producers only supply Botox to clinics approved to use the drug.

CFDA Statement (Chinese)

CDSCO Prepares Industry for Expansion of Online Portal to BA/BE Filings

The Drug Controller General of India (DCGI) GN Singh has written to drug testing and manufacturing trade groups to prepare them for the expansion of DCGI’s online portal. Singh is planning to start using the Sugam portal for filings for no objection certificates regarding bioavailability and bioequivalence.

To prepare contract research organizations, drug manufacturers and other companies for the switch to the online portal, the Central Drugs Standard Control Organization (CDSCO) convened a meeting in New Delhi this week. The regulator planned to use the meeting as an opportunity to provide a live demonstration of the software and gather feedback from those affected by the expansion of its use to applications for bioavailability and bioequivalence no objection certificates.

While the Sugam system has been in use for certain regulatory mechanisms since late last year, there is still a chance that companies using it for the first time will find fault with the software. This has been the case during the rollout of the portal to other areas of the industry. Notably, the cosmetics industry expressed concerns with validation of the online application system and others have questioned the work of the Centre for Development of Advanced Computing (CDAC).

Last month, Singh tasked CDAC with ensuring Sugam is a “flawless operational platform,” a command that suggests the system at that time was flawed in some regards. The phased rollout of Sugam was designed to mitigate the impact of these flaws by giving CDSCO time to make improvements before it was used widely. The latest step in this process is the collection of feedback from the bioavailability and bioequivalence sector.

DCGI Letter

Lack of Experts Forces India to Cancel Neurology and Psychiatry Meeting

CDSCO has canceled a neurology and psychiatry subject expert committee because of a shortage of experts. The cancellation comes two months after CDSCO invited experts in neurology and psychiatry to apply to join the pool of people the regulator uses for its committees.

The neurology and psychiatry subject expert committee was due to meet on 12 July, but CDSCO was forced to cancel the event. CDSCO cited the “unavailability of experts” in its brief explanation for the late cancellation. The committee last met in May when its members discussed regulatory filings about nine drugs.

Such meetings are intended to give CDSCO expert guidance on the merits of filings for approval of new drugs, fixed-dose combinations and other aspects of the industry that it regulates. The experts who make up the committees must commit to three-year terms and promise to provide feedback within six weeks. In return for their services, experts receive Rs 2,500 ($37) per meeting.

The model has faced scrutiny this year. India’s top panel, the apex committee, questioned whether the people who sit on subject expert committees have a detailed understanding of certain regulatory requirements, such as those relating to clinical trials. Shortly after the apex committee made the criticism, CDSCO put out its call for additional experts to join the ranks of people it relies on.

CDSCO Notice

Other News:

CFDA has released an overview of the regulatory implications of a drug registration pilot program that was proposed by China’s State Council last month. CFDA Notice (Chinese)