On June 10, 2026, Australia's Therapeutic Goods Administration (TGA) launched a public consultation on a proposal to increase regulatory transparency by publishing Good Manufacturing Practice (GMP) inspection outcomes and GMP certificates, covering manufacturing sites both within Australia and overseas. Feedback on the consultation is due by July 13, 2026. CIRS Group has compiled and summarized the core contents of this consultation for your reference.
Background
In Australia, certain therapeutic-purpose products, such as sunscreens, are regulated by the TGA as “therapeutic goods.” Their manufacturers must comply with GMP requirements and are subject to TGA GMP inspections. To increase regulatory transparency and strengthen public confidence in the quality and safety of therapeutic goods, the TGA proposes to make publicly available the GMP inspection outcomes and GMP certificates it holds.
Key Contents of the Consultation
According to the consultation paper published by the TGA, the core points of the proposal include:
- Scope of publication: proposing to publish GMP certificates and final GMP inspection outcomes, covering domestic and overseas manufacturing sites that supply products to Australia;
- Method of publication: seeking views on how GMP certificates and inspection outcomes should be displayed on and accessed from the TGA website;
- Implementation timing: publication is proposed to commence shortly after the relevant instrument is registered on the Federal Register;
- Feedback deadline: stakeholders may submit comments by July 13, 2026.
The TGA seeks input from manufacturers, importers, and the public on how to display GMP certificates and inspection outcomes on its website, and on the scope and manner of publication.
CIRS Reminder
If implemented, this proposal will significantly increase the transparency of compliance information for manufacturing sites that supply therapeutic goods (including cosmetic-type therapeutic goods such as therapeutic sunscreens) to Australia. The main impacts on relevant enterprises include:
- Increased compliance pressure: once GMP inspection outcomes are made public, weaknesses in a company's quality system will be more visible to the market and the public; companies must continuously maintain a high level of GMP compliance;
- Brand and reputation management: GMP certificates and inspection outcomes for overseas manufacturing sites will be publicly visible; companies should assess the compliance status of their contract/toll manufacturers in advance;
- Engage in the consultation: relevant manufacturers and importers may submit feedback to the TGA by July 13, 2026, regarding the scope of publication, display methods, and protection of trade secrets;
- Track developments: follow the TGA's subsequent formal decisions and implementation arrangements resulting from the consultation.
The above is subject to the TGA's officially published text and final decision. CIRS Group will continue to track regulatory developments in Australia and globally for cosmetics and therapeutic goods, providing professional regulatory interpretation and compliance solutions.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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Further Information：
https://consultations.tga.gov.au/tga/manufacturing-gmp-certificates-inspection-outcome/
