ICH Culture: Its Maintenance and Development

Therapeutic Innovation & Regulatory Science - Tập 51 - Trang 9-10 - 2017
Hironobu Saito1,2, Masafumi Yokota1,2, Akira Kawahara1, Tatsuo Kurokawa3
1Japan Pharmaceutical Manufacturers Association, Tokyo, Japan
2Daiichi Sankyo Co. Ltd., Tokyo, Japan
3RAD-AR Council, Tokyo, Japan

Tóm tắt

The founding industry members (European Federation of Pharmaceutical Industries and Associations [EFPIA], Japanese Pharmaceutical Manufacturers Association [JPMA], and Pharmaceutical Research and Manufacturers of America [PhRMA]) of the International Council for Harmonisation (ICH) have a 25-year track record of the contribution to ICH. Given that further globalization of ICH is expected, we should value this legacy and maintain the current ICH culture and its principles of “benefit to the patients first” and “science-based approach,” through which industry members would ensure transparency and objectivity in their ICH activities. In order to maintain and develop the culture of the ICH and its current momentum, a 2-way approach is important: (1) sharing common views through dialogues among leaders of each industry association, such as through the Industry Executive Council, and (2) spreading the values through grassroots activities involving wider stakeholders in global forums such as DIA, as platforms for sharing the knowledge, views, and culture of ICH across the globe.

Tài liệu tham khảo

International Council for Harmonisation. Vision/About ICH. http://www.ich.org/about/vision.html. Accessed July 25, 2016.