Updates to Health Canada’s Quality Guidance: New Drug Submissions and Abbreviated New Drug Submissions (December 2024)
Health Canada has introduced significant updates to its Quality (Chemistry and Manufacturing) Guidance for New Drug Submissions and Abbreviated New Drug Submissions. These changes, effective December 2024, are part of Health Canada’s modernization work and reflect changes in regulatory expectations since the 2018 version.
The following key updates have been introduced:
Nitrosamine Risk Assessment (S.3.2, P.2, P.5):
While the nitrosamine risk assessment was previously covered in a separate guidance document, it is now explicitly included in this revision. The guidance emphasizes the evaluation of mutagenic impurities and control strategies for high-potency mutagenic carcinogens per ICH M7 guidelines.
Manufacturer’s Standards (S.4.1, P.5.1):
A notable change removes the previous requirement for new drugs with a Manufacturer’s Standard to meet or exceed the strictest Schedule B compendial limits for purity and potency. Instead, the updated guidance stipulates that specifications must now be acceptable to the Minister. This shift introduces some flexibility compared to the previous requirement.
Testing for Scored Tablets (P.5.4): The new guidance introduces specific testing requirements for scored tablets. Studies must evaluate the uniformity of dosage units under conditions representative of consumer use, such as manual splitting or tablet splitters.
Stability and Storage Precautions (S.7.1):
Expanded requirements for storage precautions now consider additional factors identified in stability studies. Besides the previous recommendations such as “Protect from light” or “Protect from moisture” where appropriate additional precautionary statement “Store in the overwrap provided” has been added.
For a full description of these changes, refer to Health Canada’s announcement and updated guidance document: Health Canada Guidance Updates and Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) – Canada.ca.
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