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regulatory guidance

12 April 2022
Changes to the process for including Class I non-sterile, non-measuring medical devices and Class 1 IVD medical devices in the ARTG
22 September 2020
Guidance on how to request Early Scientific Advice on a biowaiver justification
14 September 2020

This guidance describes the requirements for manufacturers and sponsors of faecal microbial transplant (FMT) products in the Therapeutic Goods (Standards for Faecal Microbiota Transplant Products) (TGO 105) Order 2020 as prepared by the Therapeutic Goods Administration (TGA).

11 September 2020
From 14 September 2020, we will publish all notifications of shortages for reportable medicines on the Medicine Shortages Reports Database
14 September 2020
This guidance is for sponsors, manufacturers and providers of faecal microbiota transplant (FMT) products
27 August 2020
Approved PI and CMI documents for OTC medicines can now be published on the TGA website
30 June 2021
TGA has published updates to the regulation of faecal microbiota transplant (FMT) products
30 July 2020
Information for manufacturers to assist them with addressing risks and meeting the Australian regulatory requirements for medical devices
4 September 2020

The TGA has adopted version PE009-14 of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP), excluding Annexes 4, 5 and 14, as the manufacturing principles for:

  • medicines and active pharmaceutical ingredients
  • biologicals that comprise or contain live animal cells, tissues or organs

PE009-14 does not apply to:

24 December 2021
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