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Posted 14 June 2016 | By Nick Paul Taylor
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 an overview of its plans for staff training over the next five years. The publication of the text follows shortly after the agency was criticized by China's top anti-corruption body for failing to implement effective hiring and education initiatives, a shortcoming that is seen as enabling unsuitable people to gain and retain important positions.
While work on the training program began before the Central Commission for Discipline Inspection (CCDI) published its report on CFDA, the text nonetheless addresses some of the issues raised by the anti-corruption agency. The training program has the overall goal of establishing a series of courses that support the development of CFDA employees' careers, continuous improvement of their skills, an overall expansion of regulatory capacity and comprehensive enhancement of the organization's ability to oversee the country's food and drug industries by 2020.
Addressing capacity constraints, one of the issues flagged up by CCDI, is a top priority for the training program. The regulator plans to work toward this and other objectives of the program by setting up problem-orientated training activities, in which CFDA staff will learn things that are relevant to their day-to-day responsibilities. CFDA sees these targeted training activities addressing current gaps in the knowledge and capabilities of its workforce. If this model is to work effectively, CFDA will need a clear understanding of existing knowledge gaps, information it plans to gather through a research agenda.
The research initiative will necessitate the gathering of information on regional outposts of CFDA. As in other initiatives underway at CFDA, the implementation of the training program in provincial parts of the regulator is a key consideration in the 2016-2020 education agenda. The regulator wants to ensure that all of its units fully understand the aims and activities that are central to the new training program. CFDA intends to closely monitor the implementation of the program to ensure regional offices are adopting the stronger leadership and education initiatives it advocates.
Regional offices are expected to increase investment in training to support this escalation in their education activities, although the program outlined by CFDA makes no mention of where the money will come from or how much it expects teams to allocate to the agenda. Similarly, the program makes no direct references to the "party building " activities CCDI wants CFDA to implement to improve the status and standing of the Communist Party of China. Such topics could be covered by proposed modules on "the socialist rule of law, " though.
If implemented effectively, these modules could address CCDI's concerns about the extent to which CFDA is promoting party building, while the training program as a whole appears designed to try to fix capacity constraints, inconsistencies in the actions of inspectors and other perceived failings.
CFDA Statement (Chinese)
The Central Drugs Standard Control Organization (CDSCO) of India has added registration of ethics committees to the list of regulatory processes covered by its online portal, Sugam. CDSCO expects all registrations related to ethics committees to go through its online portal as of this week, although it will still accept paper filings for the next month in the event of technical malfunctions.
Dr. GN Singh, the Drug Controller General of India (DCGI), outlined the adoption of Sugam for ethics committee registrations in a letter that also covered the use of the portal by cosmetics companies. Both regulatory processes are due to move over to Sugam this month, but, while the portal has been in use for other tasks since late last year, CDSCO is still conscious of the potential for technical failings to prevent companies from accessing the system. As such, Singh will accept hard copy filings for one month from organizations that were unable to make a submission online.
The flexibility shown by the regulator is potentially a reaction to criticisms of the readiness of Sugam to handle the additional tasks. In his letter to the industry, Singh wrote: "It was observed that the system is not operative satisfactorily due to non-validation of the regulatory requirement by [the Centre for Development of Advanced Computing (CDAC)]. Concern has also been raised by the cosmetics industry with respect to the validation of the online application system. " Singh appears to accept some of the criticisms.
A CDAC official has been tasked with developing a "flawless operational platform, " a statement that suggests the current portal is falling short in some regards. CDSCO has tried to mitigate the teething problems associated with the implementation of new IT systems by adopting a phased introduction of Sugam. The portal will become operational in November, at which time it handled requests related to the registration and import of drugs. Since then, CDSCO has broadened the range of process covered by the portal, culminating in the addition this month of cosmetics and ethics committee registrations.
CFDA has begun a probe into the integrity of data generated in clinical trials of medical devices. The regulator is planning risk-based spot checks, targeting Class III medical devices in particular, to assess whether clinical trials generated legitimate data and were otherwise compliant with its requirements.
As of 1 June, CFDA has embarked on a retrospective examination of registration trials of medical devices. The regulator is paying particular attention to clinical trials of Class III medical devices, those that are perceived to pose the greatest risk to human health, and studies that generated data to support an application to import a product. Once CFDA has used its risk-based model to decide on which trials to assess, it plans to notify clinical testing facilities of its intent to review their operations and send its teams in to conduct on-site inspections.
CFDA is tasking its inspectors with confirming the authenticity of data generated in clinical trials at the facilities. The regulator is particularly keen to identify any illegal falsifications. Officials will assess the traceability of data, the legitimacy of the product being tested, the consistency of applications for registration and other compliance matters before deeming whether the filing the clinical trial was run in support of is legitimate. CFDA will dismiss submissions based on inauthentic data, while assessing the merits of filings underpinned by trials with less serious compliance issues on a case-by-case basis.
The probe is reminiscent of the self-audit program CFDA initiated to cut its backlog of drug approval applications. As in that earlier program, the focus of the medical device probe is on identifying filings that are based on questionable data and removing them from the backlog before they take up more of CFDA's resources. CFDA has given medical device companies the same self-regulation option it offered to drug developers. This allows companies that know their filings are based on dodgy data to withdraw their submissions. CFDA trimmed its drug submission backlog using this mechanism.
CFDA Notice (Chinese)
A Chinese academic has written an analysis of the planned overhaul of the drug registration process in China. The analysis, which CFDA published on its website, outlines the intentions of the changes and puts them into context. Wang Chenguang, a law professor who studied at Harvard University, wrote the piece. Wang Analysis, More (both Chinese)
Tags: Asia Regulatory Roundup, Regulatory Roundup
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