Updates - Mutual Recognition Agreements

Date of last update: April 4, 2012

Canada is a participant to Mutual Recognition Agreements (MRAs), covering drug/medicinal products Good Manufacturing Practices (GMP) Compliance Programmes, with the Parties listed below:

• European Community (EC)
  • Status summary - Update
  • Regulatory Authorities
• Switzerland
  • Status summary - Update
  • Regulatory Authorities
• European Economic Area - European Free Trade Association (EEA EFTA) States: the Republic of Iceland, the Principality of Liechtenstein and the Kingdom of Norway
  • Status summary - Update
  • Regulatory Authorities
• Australia
  • Status summary - Update
  • Regulatory Authorities

The equivalency of the GMP Compliance Programmes is determined according to a three (3) phase confidence building process:

1. Documentation review;
2. Evaluation of processes and procedures including an on-site evaluations; and
3. Decision making on the results of the evaluation.

The results of the evaluation are based on objective assessment criteria and documented evidence and are used to determine equivalency. The evaluation results remain valid as long as the agreement between the two parties is in effect and where no significant changes to the GMP Compliance Programmes have been introduced.