ICH Project 53rd ICH Public Meeting (Online)
July 13, 2026
To widely share information on ICH developments with representatives from companies involved in pharmaceutical development and safety and quality assurance, as well as the general public, the 53rd ICH Immediate Report Meeting will serve as a forum for presenting and reporting on the outcomes of the ICH Rio de Janeiro 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 report on ICH trends, including the results of the Rio de Janeiro meeting, followed by 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 (Ministry of Health, Labour and Welfare) | |
| Masafumi Yokota (JPMA) | |
| 02 S13 EWG: Nonclinical Safety Testing of Nucleic Acid Medicines | Takasumi Shimomoto (NIH) |
| 03 E21 EWG: Inclusion of pregnant and breastfeeding individuals in clinical trials | Yoko Motoki (NIH) |
| 04 E22 EWG: General Guidelines on Patient Preference Studies | Shun Tezuka (NIH) |
| Ryota Kimura (NIH) | |
| Keiji Hirabayashi (NIH) | |
| 07 M13 EWG: Bioequivalence of Immediate-Release Oral Solid Dosage Forms | Hideaki Kuribayashi (NIH) |
| Naohiro Otaki (NIH) | |
| 09 M4Q(R2) EWG: Revision of the “Guideline on the Preparation of CTD Quality Documents” | Hiroki Ito (JPMA) |
| 10 Q1 EWG: Revision of the Guidelines for Stability Testing of Drug Substances and Drug Products | Tatsuo Koide (National Institute of Health Sciences) |
| Keita Kawaji (NIH) | |
| Atsushi Nishikawa (NIH) | |
| 13 Q6(R1) EWG: Revision of “Establishment of Specifications and Test Methods for Medicinal Products” | Takahiro Yamaguchi (JPMA) |