ICH announces Q&A Document on Q11 Guideline – Main Focus: API Starting Materials

New Drug Approvals

The ICH has recently published a Business Plan and a Concept Paper on the elaboration of a Q&A document on the ICH Q11 Guideline. Read more here.


ICH announces Q&A Document on Q11 Guideline – Main Focus: API Starting Materials

The ICH Q11 Guideline entitled “Development and Manufacture of Drug Substances” from May 2012 has been implemented in the three ICH regions EU, USA and Japan for 2 years now. It describes the approach to developing APIs based on an in-depth understanding of the manufacturing process and adequate strategies to control this process. The document indicates what information should be provided about the quality of the API in Module 3 of the CTD (Common Technical Document) within the framework of a marketing authorisation application.

In the meantime, there has been an accumulation of cases where the applicant and the regulatory authorities adopted different positions with regard to…

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