Increasing transparency of Good Manufacturing Practice (GMP) inspection outcomes

Between 10 June 2026 and 13 July 2026, we undertook a public consultation seeking feedback on a proposal to publish Good Manufacturing Practice (GMP) inspection outcomes for Australian and international manufacturers, and GMP certificates issued to international manufacturers.

We received 67 submissions from sponsors, manufacturers, industry associations, healthcare professionals and members of the public.

There was overwhelming support for the proposal, with 64 respondents supporting the publication of GMP certificates for international manufacturers and 57 respondents supporting the publication of GMP inspection outcomes. Stakeholders were broadly of the view that publication would improve understanding of the TGA's regulatory oversight of manufacturers and increase transparency of regulatory activities.

Respondents also raised several implementation considerations, including:

• the need for clear explanatory information and guidance to support interpretation of published information,
• protecting commercially sensitive information and ensuring published information is used within its intended regulatory context,
• differing views on the scope of information to be published, with some respondents supporting publication of additional inspection, and compliance information, while others preferred a more limited approach
• whether publication should apply only to future inspections or include a limited period of historical inspection outcomes.

All submissions that gave permission to be published on our website are available through the ‘View submitted responses’ link below.

We appreciate all the feedback and thank respondents for their submissions.

We carefully considered all submissions received during consultation and will proceed with publishing GMP inspection outcomes for Australian and international manufacturers, and a modified version of overseas GMP certificates, rather than the certificates themselves, to maintain the integrity of the certification framework and reduce the risk of unauthorised reproduction. Consistent with the final approach adopted following consultation, publication will commence on a prospective basis only and information will be published on a routine monthly publication cycle.

A summary of the feedback received, the TGA's response to issues raised by stakeholders, and the final implementation approach is provided in the Increasing transparency of GMP inspection outcomes – Consultation outcomes paper.

The TGA intends to register a legislative instrument to enable publication of prospective GMP inspection outcomes and overseas GMP certificates on the TGA website. Publication is expected to commence following registration of the instrument.