On August 1, 2025, the draft (Step 2b) ICH guideline for Extractables and Leachables (Q3E) was posted on the ICH website. The consensus draft guideline was agreed upon by the ICH Expert Working Group (EWG) and transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation. The open public consultation is expected to close in most regions in December 2025 and the EWG will review all comments and consider the need for any revisions to finalize the document, ideally by June 2027. This guideline, when finalized, will be the first international guideline for extractables and leachables for pharmaceutical products and will ultimately include new qualification thresholds for safety that guide the selection of appropriate analytical methods. The ICH Q3E draft document provides recommendations for the identification and assessment of potential leachables in drug products that may arise from upstream manufacturing equipment and the primary and secondary container closure systems. It delineates a framework that follows the principles described in the ICH Q9 Quality Risk Management guideline that includes considerations throughout product development, including materials characterization and process understanding. However, because the primary purpose is to protect patient safety and product quality through assessment and control of leachables in the drug product, the quality guideline also includes considerable toxicological risk assessment recommendations. The webinar will summarize the history of the guideline, provide an introduction to the draft recommendations for the quality risk assessment, explain the source of the proposed draft qualification thresholds, provide an overview of the toxicological risk assessment recommendations, and illustrate key challenges with the qualification of leachables from container closure systems.