6 September 2017

The ICH Q11 Q&A reached Step 4 of the ICH Process in August 2017 and now enters into the implementation period (Step 5). These Q&As are intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials and on the information that should be provided in marketing authorisation applications and/or Master Files. The focus of the Q&A document is on chemical entity drug substances.

The ICH Q11 Q&A is available for download on the Quality Guideline page of the ICH website.