The Q&As are intended to provide additional clarification on the considerations for the selection 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.
ICH points out that “Applicant” is used throughout the Q&A document and should be interpreted broadly to refer to:
Designation of starting materials should be based on process knowledge for the intended commercial process. It is emphasized that all of the general principles in ICH Q11 Section 5 should always be considered holistically, together with the clarifications in this Q&A document, rather than applying a single general principle or Q&A clarification in isolation.
Comments on the draft document can be submitted until January 31, 2017. A final version (Step 4) of the Q&A document can be expected in November 2017.