Posted by Michael Wonder on 01 Nov 2018
Update on the Australia-Canada Mutual Recognition Agreement
1 November 2018 - Common Statement regarding inclusion of Active Pharmaceutical Ingredient in Australia-Canada Mutual Recognition Agreement (as of November 1, 2018).
On November 8, 2013, new regulatory amendments for mandatory Good Manufacturing Practices (GMP) of Active Pharmaceutical Ingredients (API) intended for use in human drugs came into force in Canada. The implementation of these regulatory amendments under the Food and Drug Regulations enable Health Canada (HC) to include APIs under the operational scope of its existing Mutual Recognition Agreements (MRAs).
As of November 1, 2018, Health Canada and the Therapeutic Goods Administration (TGA) of Australia concluded an agreement to include APIs under the scope of the Mutual Recognition Agreement on Conformity Assessment in Relation to Medicines Good Manufacturing Practice Inspection and Certification between the Government of Canada and the Government of Australia. As a result the TGA will accept GMP Certificates of Compliance (or equivalent), issued by Health Canada under this MRA, for APIs manufactured in Canada, in support of a GMP Clearance application.
