Health Canada agreement on GMP inspections

The Therapeutic Goods Administration (TGA) and Health Canada have signed a Memorandum of Understanding (MoU) to further increase collaboration and reliance on Good Manufacturing Practice (GMP) inspections conducted in countries outside each other’s borders (referred to as extra-jurisdictional inspections). 

This agreement builds on the existing Mutual Recognition Agreement that entered into force on 1 January 2006 for GMP inspections performed within each other’s jurisdictions.

TGA and Health Canada are both members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) - external site and the Access Consortium and have a long history of close collaboration in GMP inspections.

What this means for Australian sponsors

From 1 March 2024, sponsors providing GMP evidence from Health Canada inspections in third countries as part of certain GMP Clearance applications will: 

• require less documentary evidence 
• not be charged compliance verification fees 
• undergo abbreviated GMP Clearance assessments.

Due to differences between the respective regulatory frameworks, these benefits will only apply to:

• Active Pharmaceutical Ingredient (API) manufacturers
• contract testing laboratories
• contract sterilisers.

Further information will be published in the next revision of the GMP Clearance guidance following consultation with the TGA-Industry Working Group on GMP (TIWGG).