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Health Canada Adopts ICH Guidelines for Drug Substances, Residual Solvents

April 9, 2018

Health Canada adopted the ICH’s Q&A guideline on the development and manufacture of drug substances as well as a separate guidance on residual solvents.

The agency said it “recognized that the scope and subject matter of current Health Canada guidances may not be entirely consistent with those of the ICH guidances,” and noted that in such circumstances “Health Canada-implemented ICH guidances take precedence.”

When choosing and justifying starting materials, applicants should consider both the general principles in ICH Q11 and the clarifications in the Q&A document, according to the guidance, titled Q&A: Selection and Justification of Starting Materials for the Manufacture of Drug Substances.

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