EMA Shares Industry Feedback on Upcoming Extractables and Leachables Guideline

The European Medicines Agency has published stakeholder comments on the proposed ICH Q3E Extractables and Leachables guideline, offering valuable insight into ongoing discussions and regulatory expectations.

The draft ICH Q3E guideline, released last year for public consultation, aims to create a unified scientific framework for evaluating extractables and leachables (E&Ls) arising from packaging materials, medical devices, and manufacturing processes. This marks a significant step toward harmonising global standards in pharmaceutical development, approval, and lifecycle management.

Feedback was submitted by industry players, associations, and expert groups, highlighting key concerns and areas needing further clarification. By making these comments public, the EMA provides transparency into the evolving regulatory landscape and signals which topics may undergo refinement before finalisation.

The release of these insights is expected to guide companies in aligning with future compliance requirements and preparing for implementation once the guideline is finalised.

27-03-2026