Health products compliance: International agreements and collaboration activities
This page provides a summary of Health Canada's Regulatory Operation and Enforcement Branch international collaboration on medicines between Canada and International partners.
MRA - Mutual recognition agreements on drugs/Medicinal products good manufacturing practices compliance programmes
- Background
- MRAs Updates
- Internationally Harmonized Requirements for Batch Certification
- Standard Operational Procedure for the Determination of Equivalency of Inspection Methods
Some of the hyperlinks provided are to sites of organizations or other entities that are not subject to the Official Languages Act.
The material found there is therefore in the language(s) used by the sites in question.
Partnerships
- PIC/S - Pharmaceutical Inspection Co-operation Scheme
- WHO - World Health Organization
- ICH - International Conference on Harmonization
- OMCL - Official Medicines Control Laboratories
- ICMRA - International Coalition of Medicines Regulatory Authorities
Regulatory cooperation
- Canada-United States Regulatory Cooperation Council - RCC
- Canada-European Union Comprehensive Economic and Trade Agreement - Regulatory Cooperation Forum - RCF
Export and import
- Guidance Document on the Application for a Certificate of a Pharmaceutical Product (GUI-0024)
- Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080)
- Importing and exporting health products for commercial use (GUI-0117)
- Intention to Invoke Section 37 of the Canada Food and Drugs Act for Products being Exported
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