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ICH Q11: Draft Q&A Document Reaches Step 2b

The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) regarding the selection and justification of starting materials, reached Step 2b of the ICH process and enters the consultation period.


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:

  • the marketing authorization holder
  • the filing applicant
  • the drug product manufacturer, and/or
  • the drug substance manufacturer.

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.


ICH: Newsroom



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