A summary of recent TGA regulatory updates

As Australia continues to improve its regulatory framework, the Therapeutic Goods Administration (TGA) has regularly released new and updated materials concerning the regulation of both medicines and devices. A summary of the recent updates are provided below.

Clinical evidence guidelines: medical devices

These guidelines have been developed with the intention of aiding manufacturers of medical devices (including In vitro diagnostics (IVDs)) on what can be considered clinical evidence and the process of generating clinical data for evaluation. The majority of the guidance is split into two parts, the first on general requirements with the second covering more detailed information on specific high-risk devices. The document has been updated to Version 2.0 as of March 2021, however it notes that the document is incomplete (particularly in reference to IVDs) and that it will evolve over time with updates and further clarifications as required.

Building a more robust medicine supply consultation

This public consultation has been launched to gather feedback on reforms developed to ensure a reliable supply of important medicines in Australia. Having identified an absence of regulatory pathways that facilitate registration on the Australian Register of Therapeutic Goods (ARTG) which could lead to medicines shortages, four approaches to combat this potential issue have been developed. These four proposals form the focus of the consultation:

  • Prioritising evaluation of important generic medicines
  • Mitigating the effects of a medicine shortage
  • Improving reliability of supply for known shortages
  • Managing alternative supply if medicines are discontinued

The consultation closes on 17 May 2021.

New standard for serialisation and data matrix codes on medicines

From 01 January 2023, a new standard for the serialisation of medicines and use of data matrix codes (TGO 106) will come into effect. The new standard has been introduced in attempt to align with global stands and provide consistency for sponsors and manufacturers operating on a global scale. Whilst it is not mandatory to use data matrix codes or serialisations of medicines, TGO 106 sets out the requirements for sponsors who choose to do so.

Medicine labels: Guidance on TGO 91 and TGO 92

Labelling requirements differ between prescription and non-prescription medicines and these requirements are set out in two separate labelling orders, TGO 91 (prescription) and TGO 92 (non-prescription). From 01 September 2020, TGO 91/92 replaced the previous requirements and a 4 year transition period began. In order to assist sponsors and manufacturers, a 4-part guidance has been released by the TGA. Additionally, a help card for TGO 91 was simultaneously released to provide practical guidance to sponsors, distributors and retailers on designing and updating compliant prescription medicine labels.