ICH Project 53rd ICH Public Meeting (Online)
July 13, 2026
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 53rd ICH Immediate Report Meeting(May 30–June 3, 2026), we will host the 53rd ICH Public Meeting online on July 14, 2026.
At this briefing, we will first provide an update on ICH trends, including a report on the outcomes of the Rio de Janeiro meeting. We will then feature presentations and Q&A sessions with experts from each working group on safety, efficacy, cross-cutting issues, and quality.
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 14, 2026, 1:00 PM – 5:05 PM | Online (Zoom) |
Information and Program
Presentation Materials
| Presentations | Speakers |
|---|---|
| Fumiya Tamura (MHLW) | |
| Masafumi Yokota (JPMA) | |
|
02 S13 EWG: Non-clinical Safety Evaluation of Oligonucleotide-based Therapeutics | Takami Shimomoto (PMDA) |
| 03 E21 EWG: Inclusion of pregnant and breastfeeding individuals in clinical trials | Yoko Motoki (PMDA) |
|
04 E22 EWG: General Consideration for Patient Preference Studies | Shun Tezuka (PMDA) |
| Ryota Kimura (PMDA) | |
|
06 M7 Sub-group: Addendum to ICH M7 on Risk Assessment and Control of Nitrosamine Impurities | Keiji Hirabayashi (PMDA) |
|
07 M13 EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms | Hideaki Kuribayashi (PMDA) |
| Naohiro Otaki (PMDA) | |
| Hiroki Ito (JPMA) | |
|
10 Q1 EWG: Stability Testing of Drug Substances and Drug Products | Tatsuo Koide (NIHS) |
| Keita Kawaji (PMDA) | |
| Atsushi Nishikawa (PMDA) | |
| Takahiro Yamaguchi (JPMA) |