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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) 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).