Launch of a pilot good manufacturing practice single inspection program

Drug Establishment Licensing Bulletin 168, February 27, 2024

Launch of a pilot single inspection program: a global approach to good manufacturing practice (GMP) inspections of third country manufacturers.

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About the pilot

Health Canada has begun piloting a GMP single inspection program with the Therapeutic Goods Administration and the Medicines & Healthcare products Regulatory Agency. These 3 regulatory authorities are all members of the:

This pilot aims to establish a coordinated global approach to GMP inspections of foreign manufacturing sites of common interest. Using our collective inspection resources, each authority has agreed to cover the scope of the other where possible. This reduces the need for multiple inspections of the same site.

This builds on the success of our existing collaborative GMP arrangements and will allow for:

Impact on Canadian drug establishment licence holders

We're currently identifying sites to inspect as a part of this pilot. We may contact you if we select one of the foreign buildings listed on your drug establishment licence (DEL).

There will be no changes to the process to:

Contact us

Contact us with questions about the pilot program.


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