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).
In Australia, manufacturers of APIs are regulated under the Therapeutic Goods Act 1989 ('the Act') and the Therapeutic Goods Regulations 1990 ('the Regulations'). API manufacturers located in Australia are required to hold a GMP licence that authorises the manufacture of APIs (unless specifically exempt under the Regulations).
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.
Benefits to the MRA Agreement
Australian sponsors who source APIs from Canada will continue to benefit from the existing MRA pathway which requires a reduced level of documentary evidence, compared to the Compliance Verification pathway.
If you have any questions please contact the Manufacturing Quality Branch.