ICH Project 51st ICH Public Meeting (Online)

June 30, 2025

To widely share information on ICH developments with representatives from companies responsible for drug development and ensuring safety and quality, as well as the general public, the 51st ICH Immediate Report Meeting will be held on July 1, 2025, as a forum for presenting and reporting on the outcomes of the ICH Madrid Meeting (Madrid, Spain,May 10–14, 2025), we will host the 51st ICH Public Meeting online on July 1, 2025.

At this briefing, we will first report on ICH trends, including the results of the Madrid meeting, followed by presentations and Q&A sessions with experts from each working group on efficacy, quality, and cross-cutting areas.
The program and schedule for this briefing are attached below as a file, which you can view directly.
Please note that unauthorized copying or reproduction of the attached content is prohibited.

Date, Time, and Venue

Date and Time Format
Tuesday, July 1, 2025, 1:00 PM – 4:35 PM Online (Zoom)

Information and Program

Event Information / Program

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Presentations Speakers
01-1_ICH Trends Fumiya Tamura (MHLW)
01-2_ICH Trends - From the Perspective of the JPMA- Masafumi Yokota (JPMA)
02_E6(R3)EWG: Revision of the Guideline for Good Clinical Practice Hiromi Takizawa (PMDA)
03_E22 EWG: General Considerations on Patient Preference Studies Shun Tezuka (General Organization)
04_Q3E EWG: Guideline for Extractables and Leachables Kazuhiro Komatsu (JPMA)
05_Q6(R1): Revision of the Specifications Guidelines Atsuko Rōyoku (PMDA)
06_M4Q(R2) EWG: Revision of "the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality" Keisuke Tanaka (PMDA)
07_M7 Sub-group: Addendum to "Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk" Keiji Hirabayashi (General Organization)
08_M11 EWG: Clinical electronic Structured Harmonised Protocol Hiroshi Sakaguchi (PMDA)
09_M13 EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms Hideaki Kuribayashi (PMDA)
10_M14 EWG: General Principles on Planning, Designing, Analysing, and Reporting of Non-interventional Studies That Utilise Real-World Data for Safety Assessment of Medicines Kazuhiro Kajiyama (PMDA)
11_M15: General Principles for Model-Informed Drug Development Daisuke Iwata (PMDA)
　

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