The TGA has published new guidance on GMP requirements for medicinal products: PIC/S Guide to GMP PE009-16 – Version 16 of the GMP Code that was recently adopted as the TGA Manufacturing Principles.

The guidance provides comments against each of the clauses in the newly adopted Annex 16 (Authorised person and batch release) relating to Release for Supply, as well as minor changes to Annex 13 (Investigational Medicinal Products).

CMA is concerned that there is conflicting information given to industry about clause 1.7.3 (sharing of audit reports) in the guidance and the accompanying TGA webpage, which is compounded by the lack of publication of the ‘Interpretative Guidance’ that was expected to be simultaneously published in early June.

While the TGA have stated that the TGA policy about sharing of audit reports is being resolved currently and the Interpretative Guidance drafted, and this will be consulted with CMA prior to publication, it will mean that the publication will not occur until well into the transition period for Annex 16 (ending 3 September 2024).

Consequently, as there is currently insufficient clarity for manufacturers to understand their obligations, CMA have lodged an objection to the required expectations and timeframes for manufacturers published on the TGA webpage.

CMA recommends that all manufacturers of listed medicines, including all Authorised Persons conducting Release for Supply, read the todays’ full tech alert for all context and details.