ICH Project ICH Q3E "Draft Guidelines for Extractables and Eluates for Pharmaceuticals" Information Session
Sep 24, 2025
The ICH Q3E Expert Working Group (EWG) has continued to study the preparation of ICH Q3E "Guidelines for Extractables and Eluates of Pharmaceuticals". 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, the public comment on ICH Q3E "Draft Guideline for Extractables and Eluates of Drugs" is scheduled to be started soon.
In order to promote understanding of the draft guideline and to support the collection of public comments, a briefing session on ICH Q3E "Draft Guideline for Extractables and Eluates of Drugs" will be held.
Details of the briefing can be found on the PMDA website below.
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