China’s CFDA is flexing its muscles, CFDA leadership, speaking at CIMDR in Chengdu last month set out how the CFDA is stepping up postmarket monitoring of manufacturers and cracking down on submission fraud.
For China watchers, it’s always attending the China International Medical Device Regulatory Forum is a must. Run by the CFDA’s international division – the China Center for Food and Drug International Exchange (CCFDIE), CIMDR is now the largest and arguably most important event on the international medtech regulatory calendar. This year was no exception, with speeches from the Chinese Vice Minister Jiao Hong, responsible for CFDA, as well as the CFDA leadership team, setting out the Agenda for ongoing regulatory reform.
Of course there’s always a large domestic audience at CIMDR, and some of the news was clearly directed to the domestic audience. AS China steps up its regulations, it’s always easy to assume that this is directed at making things more difficult for importers. However it’s important to understand that there’s a very substantial domestic reform agenda aimed at boosting the standards and compliance of the local industry. Some highlights from the CIMDR illustrate the kind of reforms being attempted.
- Cracking down on clinical data fraud
Following efforts to clean up fraud in medicines clinical trials, there’s now a similar initiative in the devices sector. CFDA intends levying fines of 50-100,000 RMB on transgressors, as well as a much more powerful penalty of imposing a ban on further regulatory submissions. Some 51 Chinese manufacturers have accepted CFDA’s invitation to come forward and”Self-declare” that their clinical data were false, and withdraw their regulatory submissions.
- Unannounced Domestic GMP Inspections
China’s domestic industry still has some way to go in achieving international standards of manufacturing quality compliance. CFDA intends to begin full enforcement of GMP for Class III products this year and intends to extend this to Class I and II devices by 2018. CFDA has commenced a program of unannounced inspections of domestic manufacturers (including Chinese facilities of multinational firms). The inspections are being targeted based on postmarket intelligence, apparently to good effect: some 36 inspections have occurred so far this year, and three of those firms inspected have ceased production.
… and internationally
There’s been much attention on CFDA’s plans for international inspections. Vice Minister Jiao Hong explained that while there had been some delays to starting the international visits, the program has now started and the first audit teams left China in September to make a start on the planned 20 inspections for 2016.
- Unapproved devices – pursuing the cosmetic surgery industry
CFDA is conducting a specific campaign targeted to cosmetic clinics, concerned over widespread use of unregulated injectable cosmetic products, particularly sodium hyaluronates. These biologically derived products are closely regulated in the west ad CFDA intends to clean up practices in China.
- Regulating the Regulators
Of course China is a huge place to regulate, and a substantial amount of domestic control is exercised by Provincial FDAs,which assume responsibility for domestically manufactured Class I and II devices as well as many local audit activities (including local audits of clinical trials). There have been long standing concerns about consistency, with possible conflicts between local industry development and regulatory responsibilities. So the National CFDA is intending to audit their provincial counterparts – and to publish the findings. Look out for the league tables!
- Priority access
Following on the heels of the expedited review pathway for innovative devices, CFDA recently announced a planned Priority Review pathway. This time the priority will be given to areas of stated clinical need and to devices addressing national research priorities. Essentially – an assistance to local manufacturers responding to provincial and national R&D initiatives.
Finally, remarks by CFDA’s Director of Regulations Zhang Qi, were particularly telling. Put simply, China sees a need for domestic structural reform in supply. There’s currently an excess of high volume, low value, “me too” products, and a shortage of high value higher tech devices where China still relies heavily on imports. China is essentially capacity building. The regulator is working to strengthen compliance and lift standards across the sector, while the local industry is also receiving generous public and private support, as well as a helping hand from CFDA in the form of priority review programs.
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