ICH Project Briefing on ICH Q1 "Draft Guideline for Stability Studies of Active Pharmaceutical Ingredients and Dosage Forms" (Step 2 document)
May 28, 2025
The ICH Q1 Expert Working Group (EWG) has been studying to develop ICH Q1 "Guidelines for Stability Studies of Drug Substances and Dosage Forms". As a result, ICH Q1 "Draft Stability Study Guideline for Drug Substances and Preparations" 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 Studies of Drug Substances and Preparations" 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 briefing session on ICH Q1 "Draft Guideline for Stability Studies of Drug Substances and Drug Products" in the form of video distribution.
The details of this briefing can be viewed on the PMDA website.
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