This topic was endorsed by the ICH Assembly in June 2019.

Further to the MC’s endorsement of the Q3E Concept Paper and Business Plan in July 2020, the Q3E EWG was established to work on the development of the Q3E Guideline on the assessment and control of extractables and leachables (E&L), and is expected to assist both applicants and regulators by providing focus on critical aspects, and improving transparency in requirements for medicinal products including drug delivery device components.

Further information can be found in the Q3E Concept Paper and Business Plan.