26th December 2016
[Reference]
Office of International Regulatory Affairs
Pharmaceutical Safety and Environmental
Health Bureau
Office Director: Dr Nobumasa Nakashima
Deputy Director: Mr Yoshihiko Sano
Tel: +81-3-3595-2431 (Direct)
To the press
Results of The 6th China-Japan-Korea Director General Meeting on Pharmaceutical Affairs
The 6th China-Japan-Korea Director General Meeting on Pharmaceutical Affairs is held among MHLW/PMDA, MFDS and CFDA in Seoul, Republic of Korea on 22nd November 2016.
| (Note) | MHLW: Ministry of Health, Labour and Welfare, Japan |
| PMDA: Pharmaceuticals and Medical Devices Agency, Japan | |
| MFDS: Ministry of Food and Drug Safety, Republic of Korea | |
| CFDA: China Food and Drug Administration, People’s Republic of China |
Each participant agrees in the trilateral meeting that discussions of regulatory harmonization on clinical trials are useful among China, Japan and Korea, and that following topics are further studied:
(1) Information sharing in the field of clinical trials (coordinator: Korea)
Comparison chart of the system of clinical trials in the three countries is updated as of 2016, and its result will be posted on their own websites.
(2) Discussion on clinical trials guidelines among China-Japan-Korea (coordinator: Japan and China)
Discussions how to conduct the ICH E17 guideline in the East Asian Region, expected to be finalized in ICH in the 2nd half of 2017, will be steadily promoted in the trilateral meeting led by Japan (coordinator) and China (co-cordinator).
(3) Study on ethnic differences (coordinator: Japan)
Japan mainly continues the study on ethnic differences, and, based on progress of the research and its necessity, the discussion will continue in the framework of the trilateral meeting.
The next meeting will be held in Tokyo in 2017. The detailed date and the contents of discussions will be coordinated among the trilateral secretariats.
The collaborative activities with regulatory authorities of China and Korea well contribute to MHLW’s “International Pharmaceutical Regulatory Harmonization Strategy” and PMDA’s “International Strategic Plan 2015” both formulated in June 2015. MHLW continues to strengthen cooperative relationships with China and Korea actively to seek for enhancement of Japan’s international credibility of pharmaceutical regulations.