ICH Project The 52nd ICH Informal Meeting (Web-based)

The

52nd ICH Informal Debriefing Session (

WEB

) will be held on

December

17

, 2025 to present and report the outcome of the ICH Singapore Meeting (November 15-19, 2025) and to share information on the progress of ICH with the public and companies in charge of drug development and ensuring safety and quality of pharmaceutical products. The 52nd ICH Debriefing Session will be held on the web on December 17, 2025.

In this session, the experts from the working groups will present the results of the Singapore meeting and answer questions on quality, safety, efficacy, and multidisciplinary issues.
The program and timetable of the meeting are attached below for your direct viewing.
Unauthorized copying or reproduction of the attached contents is strictly prohibited.

Date, Time, and Location

Date and time Method of the meeting
Wednesday, December 17, 2025, 13:00-17:05 Online (Zoom)

Information, Program

Information/Program

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Presentations Speakers
01-1_Trends in ICH Fumiya Tamura (Ministry of Health, Labour and Welfare)
01-2_ICH Trends - from JPMA's point of view Masashi Yokota (JPMA)
02_Q1 EWG : Stability Testing of Drug Substances and Drug Products Junji Ohashi (JPMA)
03_Q6(R1) EWG : Revision of the Specifications Guidelines Atsuko Orai (NIHS)
04_Q9(R1) Training Group: Revision of "Guidelines for Quality Risk Management Tomonori Nakagawa (JPMA)
05_S13 EWG: Non-clinical safety study of nucleic acid medicine Takasumi Shimomoto (NIHS)
06_E14/S7B IWG: Questions and Answers on "Clinical and Non-clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects Satoshi Tsunoda (Comprehensive Research Organization)
07_E21 EWG: Inclusion of pregnant and lactating women in clinical trials Yoko Motoki (NIH)
08_E23 EWG: Consideration of the use of real world evidence (RWE) in regulatory decision making on the efficacy of pharmaceutical products Ryota Kimura (NIH)
09_M7 Sub-group : Addendum to "Guidelines for the Evaluation and Management of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Reduce the Potential Carcinogenic Risk Kiyohiro Hashimoto (JPMA)
10_M11 EWG : Electronically structured and harmonized clinical study protocol Hiroshi Sakaguchi (NIH)
11_M13 EWG : Bioequivalence of immediate-release oral solid preparations Hideaki Kuribayashi (NIH)
12_M15 EWG: General Principles for Model-Informed Drug Development Kenya Nakai (JPMA)
13_M18 EWG: Framework for determining the utility of comparative efficacy studies in biosimilar development programs
Naohiro Otaki (Japan Pharmaceutical Manufacturers Association)
 

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