China-Japan-Korea Working Group (WG) on Drug Clinical Trials

On December 17, 2009, China, Japan, and Korea participated in the second WG meeting on drug clinical trials. This meeting included China’s SFDA, Korea’s Food and Drug Administration (KFDA), and Japan’s Ministry of Health Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA). SFDA’s Director-General of the Drug Registration Mr. Zhang Wei, KFDA’s Director-General of the Drug Evaluation Department Dr. Sun-Hee Lee, MHLW’s International Planning Director Mr. Shinobu Uzu, and PMDA’s Chief Executive Dr. Tatsuya Kondo were the main representatives from each country.

The representatives agreed on the Terms of Reference of the WG. The Terms outline WG’s objectives, prospective projects, procedures, participants, and other rules. The two projects the WG works on are (1) research on ethnic factors in clinical data from the three countries, and (2) information exchange on drug clinical trials.

Project 1 is primarily focused on pharmacokinetic data from the three countries. The hope is that this analysis will determine the possibility of clinical data sharing within East Asia. MHLW/PMDA will be the coordinator of this project and will propose a detailed work plan to WG.

The second project will involve the three health authorities exchanging information on drug clinical trials both on a regular and ad-hoc basis. KFDA will coordinate this project and will provide a detailed work plan.

KFDA announced its plan to host the next WG meetings next year.