Canada and Switzerland Updates Mutual Recognition Agreement for Drug GMP Evidence 

Health Canada has recently published an update in the Drug Establishment Licensing Bulletin #187, highlighting significant expansions to the Canada–Switzerland Mutual Recognition Agreement (MRA). While the text of the MRA itself has not been updated at the time of writing, as of January 31, 2025 Canada and Switzerland has agreed that the scope of the existing agreement will be expanded to include the following changes: 

Recognition of extra-jurisdictional GMP inspections 

• Health Canada and Swissmedic will now accept GMP certificates issued from inspections conducted outside either country. This means importers can rely on these certificates when applying to amend or add foreign facilities under the Drug Establishment Licence (DEL), with certificates exchanged directly between regulators. This will streamline the DEL amendment process, as GMP evidence will not need to be submitted to Health Canada when working with a company already inspected by Switzerland. 

Inclusion of APIs and blood/plasmaderived products 

• Canada and Switzerland will also begin recognizing each other’s GMP compliance programme as equivalent when working with Active Pharmaceutical Ingredients, and stable medicinal products derived from human blood or plasma. GMP certificates issued for these products by Switzerland will now be recognized by Health Canada as evidence of GMP compliance. 

With these changes to the MRA, both countries will continue to benefit from sharing GMP certificates and relying on each other’s inspections. This includes Swissmedic’s preapproval inspections (PAIs) of Canadian sites and Health Canada’s onsite evaluations (OSEs) in Switzerland. They will inform each other, assess reports, and may invite joint participation if one regulatory authority believes it is needed. 

This will help contribute reducing the regulatory burden for any importers or clients, when demonstrating compliance to GMP for foreign sites/manufacturers, ultimately simplifying cross-border trade in pharmaceuticals between Canada and Switzerland. 

Read the full bulletin here:
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/drug-establishment-licensing-bulletin/updates-mutual-recognition-agreement-canada-switzerland.html

✉️ Need help updating your DEL or interpreting how this impacts your GMP compliance strategy? 

Contact our regulatory affairs experts today.

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