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News about GMP/cGMP

2018-11-09

Australia and Canada expand their MRA

As of November 1, 2018 the Therapeutic Goods Administration (TGA) of Australia and Health Canada expanded their mutual recognition agreement (MRA) to cover active pharmaceutical ingredients (APIs).

 

With this step taken, TGA will accept GMP certificates of compliance issued by Health Canada in submissions. Applicants can now include certificates of compliance from Health Canada in support of GMP clearance submissions to TGA.

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