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Australia: TGA Adopts PIC/S Guide to GMP Version 16: Manufacturing Principles for Medicines, APIs & Sunscreens (w.e.f 3 September 2024)

On 3 June 2024, the Therapeutic Goods Administration (TGA) amended its Therapeutic Goods (Manufacturing Principles) Determination 2024 from the version of 2020. The determination was made by the Minister for Health and Aged Care. It must be observed in the manufacture of therapeutic goods, active pharmaceutical ingredients (API), and sunscreens, at all Australian manufacturing sites.


Following the amendment of the Determination, now Australia is adopting the PIC/S Guide to Good Manufacturing Practice version 16 including the following:

  • No update or status change of Annexes 4, 5, and 14

  • Include clarifications for existing Annex 13

  • Includes new Annex 16 (Authorized person and batch release)


TGA provides a transition period from 3 June 2024 until 2 September 2024 for all manufacturers to comply with the revised guide (Annex 16) and draft plans if there are any changes needed for compliance.


Effectively from 3 September 2024, TGA is expecting all manufacturers to complete their assessment or plans to accommodate their operations while complying with Annex 16 and start implementing the revised practices. Manufacturers may refer to the table below for the transition schedule as suggested by TGA.


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