GMP V16 & Release for Supply questions

The TGA are introducing PIC/S Guide to GMP Version 16 (inclusive of Annex 13 and Annex 16), as the manufacturing principles for medicines from 3 June 2024 (PE009-16, 1 February 2022). Currently the TGA webpage does not discuss a transition however, CMA and other industry groups are discussing the length of a possible transition period with TGA.

More information from the TGA including Version 16 interpretive guidance on complying with PIC/S, which will particularly address Annex 16/ Release for Supply concerns, will be released in June. In the meantime, manufacturers can refer to this Gap Analysis between Version 15 and 16 (member login required) to help understand how TGA expectations under Annex 16 will be mitigated in the forthcoming GMP interpretive guidance.

For example, many in the Complementary Medicine industry have been concerned about Annex 16 new clause 1.7.3 (audit reports are available to the Authorised Person performing the certification). The Gap Analysis includes numerous comments against this clause, including for Listed medicines that:

The current supplier approval processes (questionnaires, testing of deliveries etc) would be considered sufficient ‘audit’ for listed medicines API manufacturer.

There is currently no expectation that additional audits will be conducted of listed medicines contract manufacturers in the supply chain in addition to those inspections conducted by the TGA or other approved regulator. 

It is deemed acceptable evidence for clause 7.4.1 that the contract manufacturer holds a TGA licence or certificate for the relevant steps in manufacture. 

CMA has joined a joint TGA-industry Working Group of the TIWG, which will rewrite the Release for Supply guidances to modernise the documents, and in view of the introduction f Annex 16. Sector specific information including on listed medicines will be included. 

To ensure the updated guidances will meet member needs, CMA is seeking your feedback on the following:

– What concerns do you have with the current Release for Supply guidances* and what could be made clearer?

– What questions or concerns do you have about Annex 16?

– After considering the Gap Analysis, how long do you think the transition period should be and what specific internal/commercial factors influence this?

– Do you have any other questions about Release for Supply to improve future guidance. Are there specific examples you would like covered in the guidance?

Please send your questions, concerns or suggested examples to clarify in guidance to as soon as possible.

Further developments will be discussed with CMA’s GMP & Manufacturing Committee, and CMA will send technical alerts when future TGA GMP guidances are published.

*Release for supply of medicines | Therapeutic Goods Administration (TGA)

Releasing medicines manufactured at multiple sites | Therapeutic Goods Administration (TGA)



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