China/Japan/Korea Tripartite Cooperation

MHLW/PMDA has been actively promoting the China/Japan/Korea cooperation.

2011

October 31

Fourth DG and WG meeting s held in Tokyo

  • Discussions on the interim reports of ongoing joint projects were made and confirmed further directions toward next phase.
  • China proposed developing a guideline for joint clinical trial in China, Korea and Japan.

2010

December 28

PDF Concept Paper of Research Project on ethnic factors in clinical data from three countries China-Japan-Korea Working Group on Drug Clinical Trials (fixed on 27th Dec. 2010) (PDF)

September 13-15

APEC Multi-Regional Clinical Trials Seoul Workshop Highlighting Korea, China and Japan Tripartite Symposium

  • the outcome of the DG Meeting
  • current situation of the three countries'cooperation

Participants List of DG meetings (2008 - 2010)

September 13

Third DG and WG meetings held in Seoul

  • PDF Terms of Reference of the Working Groups (PDF) (WG) were finalized to be published.
  • The objectives and outline of the joint research on ethnic factors in clinical data were confirmed, and the Research Group composed of experts from China, Korea and Japan was established to discuss the details as well as the timeline of the joint research project.
  • Exchange of information on clinical trials was discussed as another work item of WG.

PDF Terms of Reference of the Working Groups (PDF)

2009

December 18

Japan/Korea/China Drug Clinical Trial Symposium

The regulators, the industry, and the academia from the three countries expressed their views and hope for the tripartite enterprise.

December 17

Second DG and WG meetings held in Beijing

August 18

Working Group (WG) session held in Tokyo

  • The participating authorities cooperated in carrying out the Joint Research Project on Ethnic Factors in Clinical Data, by providing the Project with relevant clinical data and continuing discussion, in order to promote global clinical trials and share clinical data.
  • The participating authorities discussed the possibility of jointly comparing each country's drug regulatory system.
  • The participating authorities made a general discussion on mutual exchange of information.

2008

April 14

First Director-General (DG) meeting held in Tokyo

  • agreed to promote scientific research cooperation under the legal background of each country in the Joint Research Project on Ethnic Factors in Clinical Data with a view to encouraging global development and sharing clinical data.
  • initiated Information Exchange Scheme on general pharmaceutical affairs

2007

April

PDF Health Ministers' Joint Statement (PDF) among China, Korea and Japan
PDF Memorandum of Cooperation (PDF) among the Ministry of Health of the People's Republic of China, the Ministry of Health, Labour and Welfare of Japan and the Ministry of Health and Welfare of the Republic of Korea, on a Joint Response against Pandemic Influenza