ICH Project Guideline Workshops on ICH Q1 "Draft Guideline for Stability Testing of Drug Substances and Drug Products" (Step 2 document)
May 28, 2025
The ICH Q1 Expert Working Group (EWG) has been studying to develop ICH Q1 "Guidelines for Stability Testing of Drug Substances and Drug Products". As a result, ICH Q1 "Draft Guideline for Stability Testing of Drug Substances and Drug Products" reached Step 2 as of April 11, 2025 and was published on the official ICH website. On May 28, 2025, ICH Q1 "Draft Guideline for Stability Testing of Drug Substances and Drug Products" was opened for public comments in Japan.
In order to promote understanding of the draft guideline and to support the collection of public comments, PMDA has decided to hold a Guideline Workshops on ICH Q1 "Draft Guideline for Stability Testing of Drug Substances and Drug Products" in the form of video distribution.
The details of this presentation can be viewed on the PMDA Website.