International – Australia and Canada Extend Mutual Recognition Agreement to APIs

Australia and Canada have expanded their mutual recognition agreement (MRA) to cover active pharmaceutical ingredients (APIs). The change means TGA will accept good manufacturing practice (GMP) certificates of compliance issued by Health Canada in submissions.

Officials in Australia and Canada began working on an MRA covering GMP inspection and certification more than a decade ago. Since then, Canada has changed its regulations on GMPs for APIs to permit the inclusion of drug ingredients in its MRAs with other countries…