Good News For Australian Sponsors Sourcing APIs From Canada
Executive Summary
Australian and Canadian drug regulators have extended their mutual recognition agreement on good manufacturing practice inspection and certification to include active pharmaceutical ingredients.
The regulatory burden for Australian drug sponsors sourcing active pharmaceutical ingredients from Canada has been reduced following an agreement that allows the Therapeutic Goods Administration to start accepting good manufacturing practice (GMP) certificates for APIs issued by Health Canada.
On Nov. 1 the TGA and Health Canada agreed to include APIs in their existing mutual recognition agreement (MRA) on conformity assessment in relation to GMP inspection and certification for medicines.
As a result, the TGA will accept GMP certificates of compliance (or equivalent) issued by Health Canada under the MRA for APIs manufactured in Canada in support of a GMP clearance application.
Health Canada already includes APIs under the operational scope of its existing MRAs, and has done so for some time now. This was enabled by the implementation of regulatory amendments for mandatory GMPs of APIs intended for use in human drugs that came into force in Canada in 2013.
The TGA said that Australian sponsors who source APIs from Canada would now also benefit from the Australia/Canada MRA pathway "which requires a reduced level of documentary evidence, compared to the Compliance Verification pathway.”
From the editors of Scrip Regulatory Affairs.