30 November 2016

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 in November 2016 and now enters the consultation period.

The 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 draft Q11 Q&A document can be downloaded on the Quality Guideline page on the ICH website (Q11 Q&As: Selection and Justification of Starting Materials for the Manufacture of Drug Substances).

You may provide comments on the draft Q11 Q&A document by e-mailing the ICH Secretariat. More details under the Open Consultation page.

Note that stakeholders from ICH Regions are encouraged to submit their comments to their respective Regulatory Authorities.