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 the interpretation of the requirements in this guideline. Particularly, this concerned the definition of starting materials for the manufacture of APIs. The standards according to which regulatory authorities accept a specific compound as a starting material are far from uniform across the 3 ICH regions, and, all the more across Europe. It is thus obvious that this - in the context of global authorisation procedures - costs a lot of time, energy and money.

The ICH has now faced this problem and created an Implementation Working Group (IWG) which has the task of elaborating a Q&A document on API Starting Materials. As is usual in such circumstances (see also our News from 10 December 2014), the ICH has justified the necessity of the Q&A document in a Business Plan and a Concept Paper - both entitled "Q11: Q&As on Selection and Justification of Starting Materials for the Manufacture of Drug Substances". (Business Plan and Concept Paper are the 1st step of the ICH procedure consisting of 5 steps. The last step always ends with a "Harmonised Tripartite Guideline".)

The Concept Paper provides further details about the benefits expected of the Q&A document for the industry, authorities and patients:

  • The selection and justification of starting materials should be extensively harmonised.
  • The connection between the selection of starting materials and GMP aspects, control strategies, length of the chemical syntheses (number of synthesis steps) and the relevance of the manufacturing steps with regard to the API quality should be clarified.
  • It should be specified which information has to be provided in the application dossier for the justification of the selection of the starting materials.
  • The expectations regarding the lifecycle management should be explained.

This Question-&-Answer document is certainly interesting for all those confronted with diverse regulatory expectations regarding starting materials in relation to supra-regional registration and marketing authorisation procedures. Yet, according to the timing indicated in both the Business Plan and the Concept Paper, a first draft of this document (as Step 2a/b) should be released in one year at the earliest, namely in November 2015.

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