Health Canada and TGA Reduce Regulatory Burden for Some Drug Company Approvals

A new memorandum of understanding (MoU) between Canada and Australia provides that each country will officially recognize good manufacturing practices (GMP) inspections conducted outside of their respective jurisdictions and provide Certificates of GMP Compliance (CoC) valid in both countries.

Facilities and inspections outside a jurisdiction are known as “extra-jurisdictional.” Only onsite inspections will be recognized – remote and hybrid inspections are not covered. The MoU was effective on March 1, 2024.

This expanded scope will reduce the regulatory burden for Canadian importers, who will no longer need to submit GMP evidence to Health Canada for a Drug Establishment License (DEL) application when there is a valid extra-jurisdictional CoC for requested activities, dosage forms, and/or drug categories.

In other words, a certificate of compliance will be exchanged directly between Health Canada and the Therapeutic Goods Administration (TGA) in Australia.

Figure 1: Drug Establishment Licensing Bulletin 170, March 1, 2024

How is this Different?

Before March 1, 2024, Canada and Australia only exchanged certificates of compliance if inspections were conducted within their jurisdictions. For example, Canada exchanged with Australia for inspections conducted in Canada, and Australia exchanged with Canada for inspections conducted in Australia.

Importers did not have to submit a DEL application to maintain the foreign building on their license if the building held a valid certificate and the certificate supported the compliance of activities, drug categories, and dosage forms requested on the application form.

Effective March 1, 2024, Canada and Australia will exchange these certificates for inspections conducted in and outside their respective jurisdictions if the new or previously issued CoCs are within the validity period listed on the certificate and the operational scope of the agreement and MOU.

For companies importing finished dosage form products from a foreign building that is not located in Australia but has been inspected by the TGA, the company may not need to submit GMP evidence with its DEL application under certain circumstances. Active Pharmaceutical Ingredients (APIs) are within the operational scope of this agreement as well.

For more specifics, visit the Health Canada DEL page on the agency’s official website.