Health Canada Incorporates QbD in Updated Quality Guidance

Mar 04, 2014

Canada's regulatory authority, Health Canada, has mandated that all pharma companies globally applying for approval to sell drugs in Canada now need to submit quality summary documents and certifications.

Under the QbD norms, companies submitting products for approval to Health Canada will also need to submit comparability documents  with monographs of the European Pharmacopoeia and detailed drug master files that comply with the International Conference on Harmonization’s registration for human use quality standards.

The updated guidance includes guidance on how to implement Quality by Design approaches to drug development and references on how to document a QbD approach to the development of a drug substance.

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