The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Health Canada, the Therapeutic Goods Administration (TGA) and the Medicines & Healthcare products Regulatory Agency (MHRA), all members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) - external site, International Coalition of Medicines Regulatory Authorities (ICMRA) - external site and Access Consortium, have begun piloting a Good Manufacturing Practice (GMP) Single Inspection Program (SIP).
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 extend the scope of an inspection to cover products of interest to one another, where possible, reducing the need for multiple inspections of the same site.
This builds on the success of our existing collaborative GMP arrangements and will allow for more efficient inspection reliance processes, reduced regulatory burden on industry and enhanced collaboration in our regulatory oversight of common global supply chains.
What this means for Australian sponsors
There will be no change to the overseas GMP inspection or clearance application processes. The pilot is in the preliminary stages of identifying sites. If you applied for a GMP inspection of an overseas manufacturing site and the site is selected to be included in the pilot, we will contact you.
More information on the pilot will be published on our website and shared with our TGA-Industry Working Group on GMP as work progresses.