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Swissmedic: Refined interpretation of the Mutual Recognition Agreement (MRA) between Canada and Switzerland

31 January 2025

Swissmedic: Refined interpretation of the Mutual Recognition Agreement (MRA) between Canada and Switzerland

Health Canada and Swissmedic agreed to expand the implementation of their Mutual Recognition Agreement (MRA) on Good Manufacturing Practice (GMP) compliance.

As of 31 January 2025, both authorities have decided to expand the scope to include the recognition of GMP extra-jurisdictional inspection outcomes as well as active pharmaceutical ingredient and stable medicinal products derived from human blood or human plasma in the operational scope. Additionally, both authorities will implement information sharing and reliance mechanisms for Health Canada's on-site evaluations and Swissmedic's pre-approval inspections.

The MRA remains unchanged, as these updates are within the framework of the existing agreement. However, Health Canada and Swissmedic reaffirm their commitment to revising the MRA in due course to align with regulatory developments over the past 25 years.

For more information, see here.

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