Improving Global Drug Development: China, Japan, and Korea

The East Asian Pharmaceutical Regulatory Symposium was recently held April 14-15 2008 in Tokyo. At the Symposium, the Health Ministers of China, Japan and Korea agreed to promote increased clinical data sharing and encourage global drug development.

The three Ministers affirmed the importance of the three countries’ cooperation on clinical research, especially in clarifying the ethnic factors on clinical data. The State Food and Drug Administration of China (SFDA), the Korea Food & Drug Administration (KFDA) and the Ministry of Health, Labor and Welfare of Japan (MHLW) plans to establish a Joint Research Project on Ethnic Factors in Clinical Data. These ministries will also develop an Information Exchange Scheme on general pharmaceutical affairs.

To coordinate these projects, each country will have a contact point. For the SFDA, it will be the Department of Drug Safety Inspection. For the KFDA it will be the Pharmaceutical Safety Policy Division, while for the MHLW, it will be the Pharmaceutical and Food Safety Bureau, Evaluation & Licensing Division.

These three countries would work together to make sure information is shared, especially with experiences and direction for improving clinical development. The hope is to provide increased networking and collaboration in the Asian region to develop the best fit drugs for Asian populations.

The symposium also discussed the latest trends and updates in Good Manufacturing Practice (GMP) and clinical trial monitoring.

A working group (WG) will be established to promote these projects. The first WG meeting is scheduled for November 2008 in Japan.