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ANZ LRA Watchdog Update October 2022


Australia and New Zealand Legal and Regulatory Affairs
Watchdog Update
October 2022

Gabrielle O’Sullivan PhD MPH1 and Giulia Giunti PhD2

1Executive Officer, Royal Prince Alfred Hospital Institutional Biosafety Committee
Royal Prince Alfred Hospital, Australia

2Quality Manager, Malaghan Institute of Medical Research, Wellington, New Zealand



20th meeting of the Advisory Committee on Biologicals

The Advisory Committee on Biologicals (ACB) is a statutory advisory committee established by the Therapeutic Goods Regulations 1990. The 20th meeting of the ACB will take place on 10th November 2022 [1]. 


Information about the TGA's approach to Good Manufacturing Practice (GMP) inspections and clearances for overseas manufacturers of medicines and biologicals during the COVID-19 pandemic

The European Medicines Agency (EMA) has extended the validity of GMP certificates until the end of 2023.  The TGA has reviewed the effect of this extension on the MRA pathway and has created additional options for Australian Sponsors to maintain their GMP Clearance validity [2].


Update to the Manufacturing Principles for medicines, APIs & sunscreens

On 1 July 2022 the TGA adopted the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-15) issued, 1 May 2021, as the Manufacturing Principles for medicines, active pharmaceutical ingredients and sunscreens.

The changes in version 15 relate to Annex 2 - Biological Medicines, which has been split into two sub-annexes: Annex 2A 'Manufacture of advanced therapy medicinal products for human use'; and Annex 2B 'Manufacture of biological medicinal substances and products for human use'. Annex 2A contains expanded and additional guidance specific to the manufacture of ATMP medicinal products, while Annex 2B remains mostly unchanged from the Annex 2 found in version 14 of the PIC/S guide but with ATMP products excluded from the scope of application.

This adoption of the PIC/S Guide to GMP (PE009-15, 1 May 2021) commenced on 1 July 2022 from which point, GMP inspectors will use the new Guide to GMP during inspections.

Compliance with the basic requirements of the PIC/S Guide to GMP (PE009-15, 1 May 2021) is expected from the adoption date [3].


Consultation: Draft Guidance: Boundary and Combination products - medicines, medical devices and biologicals

The Therapeutic Goods Administration (TGA) is seeking feedback on the draft guidance ‘Boundary and combination products - medicines, medical devices, and biologicals’. The consultation opens on Friday 7 October 2022. Interested parties should respond by close of business Sunday 20 November 2022. Submissions now should be provided through our consultation hub [4].



MedSafe has published the agenda for the 69th meeting of the Medicines Classification Committee [5]:



Australian Register of Therapeutic Goods (ARTG): Therapeutic goods entered in the ARTG can be lawfully supplied in Australia (
Good Clinical Practice (GCP): An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials.

Good Manufacturing Practices (GMP): A set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality.

Serious Scarcity Substitution Instrument (SSSI): Serious Scarcity Substitution Instruments (SSSIs) allow community pharmacists to substitute specific medicines without prior approval from the prescriber. SSSIs are made for a defined period and may be revoked sooner.






Guidance on applying the Advertising Code rules,, published 1 July 2022, accessed 8 August 2022