Topics Held the "Japan-China ICH Joint Symposium
On June 18, 2021, the "Japan-China ICH Joint Symposium" was held online under the joint sponsorship of the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), the National Medical Products Administration of China (NMPA), and the Pharmaceutical Manufacturers Association of Japan (PMAJ).
Introduction
After China's accession to the International Conference on Harmonization of Pharmaceutical Regulations (ICH) in 2017, the implementation of ICH guidelines in China has accelerated. In view of the need for further harmonization of ICH guidelines and Chinese domestic regulations, the first bilateral ICH Joint Symposium between China and Japan was held to share the implementation status and efforts of both countries, accelerate the implementation of ICH guidelines, and deepen cooperation between China and Japan on ICH. The symposium was the first bilateral ICH joint symposium between the two countries.
Overview of the Symposium
In addition to a report on the results of the ICH Incheon Meeting in early June 2021 by the ICH coordinators of the two countries, a panel discussion on Japan-China cooperation in ICH, the latest trends in E-topics (clinical trials), the latest trends in real world data, the latest trends in Q-topics (quality), and the actual situation of cell therapy and regenerative medicine products was held. The Incheon Conference was the first of its kind in the world, and the conference was a great success.
In the report on the results of the Incheon meeting, the Chinese authorities commented that the implementation of finalized topics in China is sometimes immediate, and in other cases there is a transitional period of six months to one year, and that they would like to continue to strengthen dialogue between the regulatory authorities of both countries and focus on the implementation of ICH guidelines in the Asian region.
During the panel discussion, the National Medical Products Administration (NMPA) of China commented that there are cases where the content of the ICH guidelines does not match the regulations in China and implementation is difficult, and that they would like to learn from the situation overseas and implement the guidelines. The Pharmaceutical Manufacturers Association of Japan (PMAJ) requested that the PMAJ continue its efforts to implement the ICH guidelines and consider abolishing local guidelines that hinder the implementation of the guidelines.
Concluding Remarks
After the symposium, the participants expressed the presence of the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), and the Pharmaceutical Manufacturers Association of Japan (PMAJ) as founding members of ICH, and expressed hope that this symposium would be a catalyst for further deepening the cooperative relationship between Japan and China in the field of ICH in the future. The program of the symposium is as follows
The program of the day is shown below ( Table 1 ).
Table 1 Program
Finally, I would like to take this opportunity to thank everyone involved for their efforts in organizing this first-ever Japan-China ICH Joint Symposium.
(ICH Project, International Committee, Asia Subcommittee, China Team)