Author: Pinky Mazumder
On April 4th, 2018 Health Canada issued a Notice to announce its implementation of the ICH Q11 final guidance document on Questions and Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances. This version of ICH Q11 Question and Answers was initially published in August 23, 2017 by the ICH Expert Working Group. Implementation of this ICH guidance, enables Health Canada to endorse the principles in the guidance document. While Health Canada wishes to eliminate discrepancies between the ICH guidance documents and the Health Canada guidance documents, in case of such discrepancies, the Health Canada-implemented ICH guidance documents would take precedence.
The guidance document consists of 16 questions and answers from the ICH Working Group on the Selection of Starting Materials and Source Materials for Chemical Entities. The answers include clarifications on terminology that was previously not explained in ICH Q11, such as the meaning of “custom synthesised chemical”, which the Question and Answer document explains as a chemical manufactured to the manufacturer’s in-house or external specifications and a justification is required for its use unlike commercially available chemicals. Although ICH Q11 discusses the Development and Manufacture of Drug Substances, both Chemical Entities and Biotechnological/Biological Entities, the Question and Answer guidance document focuses on chemical entity drug substances for marketing authorization applications. Although the scope of this Question and Answer guidance does not apply to clinical trial applications, its principles may be considered throughout the clinical development stages. Moreover, a decision tree has also been provided in Annex 1 for visual assistance in the selection of justification of starting materials.
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References:
Notice: ICH Q11 Questions and Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/quality/notice-q11-questions-answers.htm
ICH Q11 Guideline: Development and Manufacture of Drug Substances (Chemical Entities and Biological/Biological Entities}: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11IWG_Step4_QA_2017_0823.pdf