ICH Project ICH Q3E "Draft Guideline for Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products" Briefing Session
September 24, 2025
The ICH Q3E Expert Working Group (EWG) has been studying to develop ICH Q3E "Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products". As a result, the draft ICH Q3E Guideline has reached Step 2 as of August 1, 2025 and has been published on the official ICH website. In Japan, ICH Q3E "Draft Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products" will soon be open for public comments.
In order to promote understanding of the draft guideline and to support the collection of public comments, ICH Q3E "Draft Guideline for Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products" Guideline Workshops will be held.
The details of the briefing can be found on the PMDA website below.