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Health Canada Adopts ICH Guidelines on Drug Substance Manufacturing, Residual Solvents

Posted 05 April 2018 | By Ana Mulero 

Health Canada Adopts ICH Guidelines on Drug Substance Manufacturing, Residual Solvents

Two guidelines on developing and manufacturing drug substances and on the pharmaceutical limits set for three residual solvents – both of which were created via the International Council for Harmonization (ICH) – were implemented in Canada on Wednesday.

ICH’s Q3C(R6): Impurities: Guideline for Residual Solvents and Q11 Q&A: Selection and Justification of Starting Materials for the Manufacture of Drug Substances were adopted in 2016 and 2017, respectively. Health Canada followed the US Food and Drug Administration (FDA), referring drugmakers to the ICH website to access the guidelines, whereas FDA releases its own versions.

FDA finalized its version of the guideline on drug substance manufacturing in February, with slight modifications to ICH’s document, such as clarifications on wording and a different Q&A format. Its recommendations on the permitted daily exposure limits for N-Methylpyrrolidone, Tetrahydrofuran and Cumene were finalized last June in three separate documents for each residual solvent.

Health Canada, in announcing the implementation of ICH guidelines, clarifies that “the scope and subject matter” of its current guidances “may not be entirely consistent with those of the ICH guidances that are being introduced.” In the event of regulatory inconsistencies, implemented ICH guidances take precedence over Health Canada’s.

In February, FDA and Health Canada jointly announced plans to meet Friday – ahead of the ICH meeting in June – for the Canada-US Regulatory Cooperation Council to discuss the areas that would benefit from regulatory harmonization. Health Canada said it plans to use the discussions to understand how the differences between its drug product regulation and that of FDA can be minimized.

Notice: ICH Q11 Questions and Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances

Notice: ICH Q3C(R6): Impurities: Guideline for Residual Solvents

Categories: Regulatory News

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