ICH Q3E: EMA publishes Comments Received

By publishing the comments received on the proposed Extractables and Leachables (E&Ls) guideline, the EMA provides insight into open questions, points of discussion and regulatory expectations.

Background

The draft ICH Q3E document has been published for comment last year. The guideline on "Extractables and Leachables" aims to establish, for the first time, a harmonised scientific framework for the assessment of E&Ls from packaging materials, application systems (devices) and manufacturing processes. The guideline is therefore of considerable importance for the pharmaceutical development, approval and life cycle management of medicinal products.

Numerous comments were received from industry, associations and expert groups during the public consultation. The European Medicines Agency (EMA) has now published the comments received during the consultation process. The published comments provide valuable insights into which aspects could play a role in the further finalisation process of ICH Q3E and in which areas further clarification or specification is to be expected.

Further information and details are available on the EMA website.