ICH Project The 52nd ICH Public meeting Webinar

December 18, 2025

The 52nd ICH public meeting was held in Japan on December 17, 2025.

This webinar aimed to provide the public with updates on the progress made during the ICH meeting held in Singapore from November 15 to 19, 2025. We started with presentations on the current situation of the ICH, and then transitioned to updates on the status of various ICH Guidelines.

The webinar is jointly organized by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ, non-profit organization), and supported by the Federation of Pharmaceutical Manufacturers’ Associations of Japan, the Pharmaceutical Manufacturers’ Association of Tokyo, Kansai Pharmaceutical Industries Association and Japan Pharmaceutical Association.

Working Language
Japanese
Simultaneous English-Japanese Interpretation
Not available
Presentation Materials
Available only in Japanese

Date and Format

Date Format
December 17, 2025, 1:00 PM to 5:05 PM Online - Zoom

Program: The 52nd ICH Public Meeting

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Presentation materials Speakers

Opening remarks

Yasunori YOSHIDA,
JPMA

01 ICH activities
- Singapore Meeting Report
 -

Fumiya TAMURA,
MHLW

02 ICH activities
- Summary of the ICH Singapore Meetings from JPMA’s Viewpoint -

Masafumi YOKOTA,
JPMA

03 Q1 EWG : Stability Testing of Drug Substances and Drug Products

Junji OHASHI,
JPMA

04 Q6(R1) EWG : Revision of the Specifications Guidelines

Atsuko OIMURA,
PMDA

05 Q9(R1) Training Group : Quality Risk Management

Tomonori NAKAGAWA,
JPMA

06 S13 EWG : Nonclinical Safety Evaluation of Oligonucleotide-based Therapeutics
Takasumi SHIMOMOTO,
PMDA
07 E14/S7B IWG : The Clinical Evaluation of QT/QTC Interval prolongation and proarrhythmic potential for non -antiarrhythmic Drugs Satoshi TSUNODA,
PMDA
08 E21 EWG : Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

Yoko MOTOKI,
PMDA

09 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,
PMDA

10 M7 Sub-group : Risk Assessment and Control of Nitrosamine Impurities

Kiyohiro HASHIMOTO,
JPMA

11 M11 EWG : Clinical electronic Structured Harmonised Protocol

Hiroshi SAKAGUCHI,
PMDA

12 M13 EWG : Bioequivalence for Immediate-Release Solid Oral Dosage Forms

Hideaki KURIBAYASHI,
PMDA

13 M15 EWG : General Principles for Model-Informed Drug Development Kenya NAKAI,
JPMA
14 M18 EWG : Framework for Determining the Utility of Conparative Efficacy Studies in Biosimilar Development Programs 
Naohiro OTAKI,
PMDA
 Closing Remarks  Haruhiro OKUDA,
PMRJ

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