ICH Project ICH M7 (Mutagenic Impurities) Guideline Workshops
October 1, 2014
Since ICH M7, “Evaluation and Control of DNA-Reactive (Mutagenic) Impurities in Medicinal Products to Reduce Potential Carcinogenic Risk,” has now been harmonized among Japan, the U.S., and the EU, we held Guideline Workshops following the program outlined below.Representatives from a wide range of companies—not limited to members of the JPMA—attended, and a lively question-and-answer session took place.
We expect that the Guideline Workshops will promote understanding of the guidelines, raise awareness of their content, and contribute to the advancement of innovative new drug development. Furthermore, work toward issuing a domestic notification is underway, and it is scheduled to be issued promptly.
The program, schedule of presentations, and presentation materials for this symposium are attached below and can be viewed directly.
Please note that unauthorized copying or reproduction of the attached materials is prohibited.
Date, Time, and Venue
| Date and Time | Location |
|---|---|
| Monday, September 29, 2014, 1:30 PM – 4:00 PM | Japan Pharmaceutical Manufacturers Association |
Information and Program
Event Notice and Program (313 KB)
Presentation Materials
| Presentations | Speakers |
|---|---|
| 00_Opening Remarks |
|
| Kazuhiro Komatsu | |
| Hisuzu Hiiragi | |
| Junichi Fukuchi | |
| 04_ Industry Expectations and Recognition of Challenges (217KB) | Tsuneo Hashizume |