CONFERENCE BACKGROUND

APEC Origin & History

This project was proposed to the Industry, Science and Technology Working Group (ISTWG)of APEC by Chinese Taipei in March 1998 and was approved in August that year. The overall objective of this project is to establish an APEC network of pharmaceutical regulatory science solving common problems and for a better mutual understanding on new drug regulatory issues.

Upon approval, a series of APEC Symposia were held. The first time was at Taipei in 2000, and has been held continuously every year afterwards, at Taipei, Tokyo, Taipei, Seoul and Taipei in 2001, 2002, 2003, 2004 and 2005, respectively. Initial work plan is to formulate the guideline and Q&A and coordinate workshop and seminar in relation to bridging study. The first three meetings intended to facilitate the registration of drugs by establishing a framework for evaluating the impact of ethnic factors in drug's effect on different populations. Since APEC 2003, the theme was enlarged from "bridging study" to "regulatory communication" in response to the implementation of International Conference on Harmonization (ICH) guidelines in the APEC.

This project allows extrapolation of foreign clinical data on new region, bringing safe and effective new drugs to APEC economies effectively via the improvement of regulatory science, and ultimately making contributions to global new drug development. With these achievements, this project was endorsed by the ICH, Global Cooperation Group as an important regional initiative in regulatory communication.

With more and more multi-national collaborative clinical studies conducted in Asian countries as part of global development, it is the time to expand the focus from "bridging study" to "global development and cooperation among Asian economies". As appeared in the Welcome Message of the 2002 meeting in Japan, "Global simultaneous development and introduction of innovative drugs is no longer a dream" and the dream is now becoming the reality. Therefore, we can open up the possibilities of the new reality with more conviction.

In the APEC 2006 symposium that is going to be held in Tokyo (October 12-13 at Royal Park Hotel), presentations will be made by regulators and industry and a panel discussion will be held related to global development and cooperation among Asian economies.

Organizing Committee

Chairman: Toshiro Nakagaki, Director, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW

Vice Chairman: Shuuichi Kishida, Senior Executive Director, PMDA

Member: Satoshi Toyoshima, Executive Director and Director of Center for Product Evaluation, PMDA

Member: Toshiyoshi Tominaga, International Planning Director (Pharmaceutical Affairs), Minister's Secretariat, MHLW

Member: Takenobu Inagawa, Office Director, Office of Planning and Coordination, PMDA

Member: Kazuhiko Mori, Associate Center Director, PMDA

Program Committee

Chairman: Satoshi Toyoshima, Executive Director and Director of Center for Product Evaluation, PMDA

Member: Toshiyoshi Tominaga, International Planning Director (Pharmaceutical Affairs), Minister's Secretariat, MHLW

Member: Kazuhiko Mori, Associate Center Director, PMDA

Secretariat

Director: Takenobu Inagawa, Office Director, Office of Planning and Coordination, PMDA

Deputy Director: Shigeki Tsuda, Division Director, International Affairs and Human Resources Development Division, Office of Planning and Coordination, PMDA

Member: Toshihiko Higeta, Deputy Director, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW

Member: Makoto Shimoaraiso, Deputy Director, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW

Member: Koichi Takahashi, Manager, Public Information Group, Office of Planning and Coordination, PMDA

■しかくPharmaceuticals and Medical Devices Agency
■しかくMinistry of Health, Labour and Welfare

Secretariat of APEC 2006 PH