Top News PMDA and JPMA to Jointly Organize "JAPAN Session" at DIA China 2024

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DIA China 2024" was held in Suzhou, China from May 16 to 19, 2024. JPMA held the "JAPAN Session" (90 minutes) on May 18 in collaboration with the Pharmaceuticals and Medical Devices Agency (PMDA).

Introduction

In recent years, innovative drug development is being carried out by bio-ventures, and it is an important issue to make such development available in Japan. This session was designed to introduce the direction of PMDA's activities in response to changes in the global drug development environment, as well as the views of companies on Japanese pharmaceutical regulations.

Session Contents

Mr. Naoyuki Yasuda, Executive Officer of PMDA, moderated the session, and speakers included Mr. Yuji Kashitani, Chairperson of JPMA's Regulatory Affairs Committee, Mr. Shigeru Nakaji, Chairperson of Drug Evaluation Committee, and Mr. Kai DING (Kyowa Kirin, China) *1 of the China Pharmaceuticals Committee as panelists.

In his speech, moderator Mr. Yasuda introduced that PMDA will strengthen its outreach activities to overseas ventures, etc. through overseas development as a direction to aim for in the new mid-term plan (PMDA's 5th mid-term plan) starting from FY2024.

Chairperson Kashitani introduced the contents of the "Study Committee on the Regulatory Affairs Committee for Strengthening Drug Discovery Capability and Securing Stable Supply" (hereinafter referred to as "Study Committee on the Regulatory Affairs Committee"), which started in 2023, examining the ongoing pharmaceutical affairs regulations from the past (necessity of Japanese Phase I before participating in international joint clinical trials (MRCT), orphan Designation System) was introduced. He also explained the benefits and satisfaction levels based on the survey of companies' current perceptions of PMDA's face-to-face advice, which the Regulatory Affairs Committee reported in February 2024.

Chairperson Nakaji introduced the contents of the "Regulatory Affairs Committee", including the further streamlining of clinical trials (eco-system) and the ideal way of investigation of drug use results, etc. Explanation was given on the usefulness of improving the clinical trial ecosystem, including streamlining clinical trial procedures such as the Central IRB, FMV, and Standardized ICF (Instructions and Consent Forms), in order to promote clinical trials in Japan.

One of the themes of the panel discussion was the consultation system, in which Dr. Kai DING compared the consultation system in Japan and China, and explained the importance of timely implementation of the consultation system to improve the efficiency of the review process by improving the quality of clinical trial plans and application materials, as well as the importance of public-private interactions, He also commented on the importance of exchanges between the public and private sectors.

Concluding Remarks

More than 100 people attended the JAPAN Session in Suzhou, and many questions were asked from the audience. In particular, there were some indications of awareness such as considering in-house development in Japan, and we were reminded that regulatory trends and expectations in Japan are very high when advancing drug development.

Finally, I would like to take this opportunity to thank everyone involved for their efforts in organizing the Japan Session at DIA China.

( Takuya Tone, General Manager, International Department)

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