ICH Project 52nd ICH Public Meeting (web-based)

December 16, 2025

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

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): Revision of the Specifications Guidelines Atsuko Orai (NIH)
04_Q9(R1) Training Group: Revision of "Quality Risk Management" Tomonori NAKAGAWA (JPMA)
05_S13 EWG: Nonclinical Safety Studies for Oligonucleotide-based Therapeutics Takasumi Shimomoto (NIH)
06_E14/S7B IWG: E14/S7B Questions and Answers-
Clinical and Nonclinical Evaluation of QT/QTc
Interval Prolongation and Proarrhythmic Potential
Satoshi Tsunoda (NIH)
07_E21 EWG: Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials Yoko Motoki (Natl.)
08_E23 EWG: Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a Focus on Effectiveness of Medicines Ryota Kimura (NIH)
09_M7 Sub-group: Addendum to "Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk" Kiyohiro Hashimoto (JPMA)
10_M11 EWG: Clinical electronic Structured Harmonised Protocol Hiroshi Sakaguchi (NIH)
11_M13 EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms 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 (NIH)
 

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