ICH Project ICH Q3E “Guideline for Extractables and Leachables (Draft)” Briefing Session
September 24, 2025
The ICH Q3E Expert Working Group (EWG) has continued its deliberations toward the development of the ICH Q3E “Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products.” As a result, on August 1, 2025, the draft ICH Q3E guideline reached Step 2 and was published on the official ICH website.In Japan as well, a call for public comments on the ICH Q3E “Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products (Draft)” is scheduled to begin shortly.
To promote understanding of this draft guideline and support the collection of public comments, we will be holding a webinar at ICH Q3E “Guideline for Extractables and Leachables (Draft)” Briefing Session.
Details regarding the briefing session can be found on the PMDA website below.