ICH Project Workshop on ICH Q1 "Stability Testing of Drug Substances and Drug Products" (Draft, Step 2)
May 28, 2025
The ICH Q1 Expert Working Group (EWG) has continued its deliberations toward the development of ICH Q1 “Guideline on Stability Testing of Drug Substances and Drug Products.”As a result, the ICH Q1 “Guideline on Stability Testing of Drug Substances and Drug Products (Draft)” reached Step 2 on April 11, 2025, and was published on the official ICH website.In Japan as well, the call for public comments on the ICH Q1 “Guideline on Stability Testing of Drug Substances and Drug Products (Draft)” began on May 28, 2025.
To promote understanding of the draft guideline and support the collection of public comments, we have decided to hold a video briefing session on ICH Q1 “Guideline on Stability Testing of Drug Substances and Drug Products (Draft).”
Details regarding this briefing session are available on the PMDA website.