Introducing Release for Supply (RFS) Services: Supporting Compliance with TGA Expectations

Before medicines can be supplied in Australia, a robust and compliant Release for Supply (RFS) process is essential. The Therapeutic Goods Administration (TGA) is placing greater emphasis on the scrutiny of RFS, particularly as part of GMP clearance applications, where they are requesting more detailed information about how products are assessed and approved for supply.

In June 2024, the TGA formally adopted PIC/S Guide to GMP Version 16, including Annex 16 – Authorised Person and Batch Release. This guidance highlights key responsibilities of Authorised Persons (APs) and their delegates, including the need for appropriate qualifications, documented training, structured procedures, and a thorough understanding of the supply chain. Sponsors, distributors, and product owners must ensure their APs are fully competent and maintain oversight of the entire release process.

To support the industry in meeting these evolving expectations, Commercial Eyes are introducing Release for Supply (RFS) services.

“Our global experience and knowledge of TGA requirements allow us to deliver a compliant, end-to-end approach to release.”
Colleen Turnbull, Senior Consultant, Regulatory, Quality and Compliance unit

Together with our established local release for distribution capabilities, we are now able to provide the full suite of release services. Our team understands the operational challenges involved in ensuring medicines meet TGA expectations. By partnering with us, organisations can gain access to experienced professionals who bring global best practices and local regulatory expertise to every batch release.

“We are currently looking for alternatives to our current RFS site and were glad to hear that Commercial Eyes can provide support. Knowing there’s a partner who understands TGA expectations gives us confidence moving forward.”
Australian Sponsor, 2025