China and USA to further strengthen cooperation in drug supervision

At the 26th China-US Joint Commission on Commerce and Trade (JCCT) held in Guangzhou, China, earlier this month, China and the United States agreed to further enhance cooperation in the field of food safety, joint actions against online sales of counterfeit drugs, drug and medical device registration approval and clinical trial, as well as dialogue on cosmetics supervision, in order to protect the health of the public.

Chinese Vice Premier Wang Yang, US Secretary of Commerce Penny Pritzker and US Trade Representative Michael Froman co-chaired the three-day conference. Wu Zhen, Vice Minister of China Food and Drug Administration (CFDA), attended the conference on behalf of the regulatory agency.

At the press conference held after the conference, Vice Minister Wu Zhen introduced the consensus reached by both sides as mentioned above and emphasized that it is incumbent upon the drug regulatory agencies of China and the USA to combat selling counterfeit drugs on-line and the two sides will continue the cooperation in this field.

Pharmaceuticals and medical devices registration and approval

The US Trade Representative said that it and China affirm the following:

• That China publishes annual reports on drugs and medical devices evaluation that include their performance efforts.
   
• That in 2014 and 2015, China issued clinical trial exemption catalogues for Class II and Class III medical devices and the Medical Device Clinical Trial Evaluation Guidelines, and will conduct relevant training.  In 2016, China will complete the drafting of the second batch of medical device clinical trial exemption catalogues in order to further expand the scope of the exemption catalogues.
   
• That China is currently refining mechanisms to communicate with registration applicants. For innovative medical devices, the CFDA will appoint dedicated personnel in the evaluation and approval process to provide guidance and promptly communicate with the applicant upon request.  For other types of medical device registration applications, relevant departments of the CFDA will conduct weekly group consultations for applicants.
   
• That the State Council Opinions on Reforming the Review and Approval Systems for Drugs and Medical Devices (State Council 2015 No. 44) is the guideline for reforming China’s drug and medical device review and approval systems.  China agrees that the CFDA will provide no less than a 30-day public comment period for implementing departmental rules and regulations, and will also abide by its technical barriers to trade (TBT) commitments.