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Posted 06 June 2017 | 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 a breakdown of the good manufacturing practice (GMP) inspections it performed last year. The report shows another year of growth in the number of inspections of overseas manufacturers ordered by CFDA, yet the agency only performed a fraction of these planned visits.
CFDA identified 49 overseas manufacturers as needing to be inspected last year. This compares to the 34 organizations CFDA planned to visit the previous year. That jump in the number of proposed inspections continues the steady growth seen since 2011, when CFDA ordered eight visits. However, the growth in the number of inspections ordered failed to translate into more on-site visits last year. CFDA visited seven of the 49 companies it earmarked for inspection.
The one-in-seven ratio of performed to ordered inspections contrasts with data from 2015. That year CFDA inspected 25 of the 34 companies it wanted to assess. CFDA delayed six of the visits until 2016 because of "foreign affairs or review," and was unable to inspect the final three sites because the companies involved refused to consent to an assessment.
In 2016, delays while "relevant formalities of foreign affairs are being dealt with" forced CFDA to push back 21 of its planned inspections into the first quarter of 2017. A further 12 inspections were pushed back until even later in 2017 because the enterprises "cannot accept inspection" any earlier than that. CFDA had more success with eight of the targeted organizations, which withdrew their import registration certificates or had their applications returned while the agency was organizing its inspections.
The regulator's inability to inspect those sites meant it conducted seven of the planned 49 GMP assessments. CFDA's report for the previous year said it would conduct six inspections in the first three months of 2016.
Three of the sites assessed last year failed their inspection, the same number as in 2015 when CFDA performed 25 on-site evaluations. CFDA's 2016 set of inspections identified three critical deficiencies and 18 major failings. The critical deficiencies related to data integrity and the consistency of production processes. In 2015, CFDA inspectors identified three critical deficiencies and 36 major failings.
CFDA released the data on the inspection of foreign manufacturers as part of a report on all of its GMP and good supply practice oversight activities. The agency's analysis of the faults found during pre-approval inspections mirror its comments on assessments of overseas manufacturers. CFDA cited data integrity and inconsistent production processes as significant problems. Specifically, the agency's teams found companies failed to retain samples and accompanying documents, making it impossible to trace test data.
Indian officials are again seeking feedback on the long-gestating plan to force manufacturers to switch from gelatin to cellulose-based capsules. The latest request for feedback comes from an expert committee the Ministry of Health convened earlier this year to consider the technical implications of the switch.
The committee wants to hear from drug capsule manufacturers, non-governmental organizations and other groups likely to be affected by the proposal. This is the first time the recently established expert committee has sought external input. However, it is not the first time the industry has had an opportunity to comment on the proposal. Last year, the Drug Controller General of India (DCGI) asked for feedback on the planned switch.
DCGI's request prompted an outpouring of criticism from the industry, members of which said it could cause "chaos" in India and the countries around the world that rely on the drugs it makes. Yet, despite resistance from the industry and doubts about the necessity of the switch, the idea is still being considered by the government.
The rise of the proposal, variants of which have been put forward and rejected in the past, began in 2015. Back then the Bureau of Indian Standards released a technical document on the use of hydroxypropyl methyl cellulose, and an advisory committee took the in-principle decision to move away from gelatin. Those events led to the 2016 DCGI consultation and this week's request for feedback by the expert committee.
Throughout the advance of the idea, observers have questioned why India would risk moving away from widely-used gelatin. Some see the switch driving up the cost of drugs, shortening their shelf life and reducing the number of ingredients manufacturers can viably formulate into capsules. With the help of industry feedback, the expert committee will now consider the more technical of these and other concerns.
The Therapeutic Goods Administration (TGA) of Australia has released details of the drugs and medical devices it tested over six months last year. Publication of the information marks the start of a TGA initiative to build a publicly accessible database of its laboratory testing activities.
TGA has discussed the proposal over the past year. The Australian government formalized the idea in April with the publication of legislation. That legislation enables TGA to publish information on its laboratory testing activities twice a year. The first release of information, covering TGA testing from May to October of last year, is now live.
The database lists the name, Australian Register of Therapeutic Goods identification and sponsor of each product. Users can also see how many batches were tested, why they were assessed and the outcome of the process. The database links to TGA publications about the outcomes of tests, such as safety alerts and recall notices. Users can filter the results by parameters relating to the products assessed and the tests they underwent.
TGA will release another batch of test results in six months. The delay between the performance of the tests and the release of information is intended to give TGA a window in which to investigate and punish noncompliance.
The Indian Pharmacopoeia Commission (IPC) is hosting a workshop on the basics of pharmacovigilance and how to set up safety monitoring systems. IPC framed the event as addressing the "urgent need" for marketing authorization holders (MAHs) to establish pharmacovigilance systems.
The stated goal of the workshop is to create an "agreeable roadmap" drugmakers and healthcare providers can use to create "harmonized and sustainable" pharmacovigilance systems. Legislation published in March 2016 made it mandatory for MAHs in India to have pharmacovigilance systems. The requirement came into force on the day the document was published 15 months ago.
IPC cited the legislation in its background for the June 19 workshop, stating that it creates an "urgent need" for MAHs to establish pharmacovigilance systems. The comment and need for the workshop suggests many organizations are yet to comply with the requirements mandated by the March 2016 legislation.
The workshop agenda allocates 30 minutes to discussing these legal obligations. Other sessions will cover the basics of pharmacovigilance and how to set up and run a system for monitoring and reporting adverse events. IPC is also devoting 30 minutes to discussing how to engage MAHs in the Pharmacovigilance Programme of India (PvPI). The PvPI session will address the "current scenario" and "a way forward."
Tags: Regulatory Roundup, Asia Regulatory Roundup
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