31 January 2025
The Canada-Switzerland MRA on Medicinal Products: Drug GMP Compliance Certification, Sectoral Annex on GMP has been in force since 2000.
- As of January 31, 2025, Health Canada and Swissmedic have agreed to expand the existing approach of recognizing GMP inspection results to include inspections conducted in countries outside the respective parties’ territories and of stable medicinal products derived from human blood or human plasma.
- In addition, Health Canada and Swissmedic have agreed to introduce processes for information exchange and reliance on product-specific on-site evaluations (OSE) by Health Canada and pre-approval inspections by Swissmedic.
The text of the MRA has not yet been revised as this interpretation was possible on the basis of the existing MRA. However, Swissmedic and Health Canada confirm their intention to revise the MRA in due course and to adapt it to developments over the past 25 years .
Source: Swissmedic