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Australia: Proposed Revision of Manufacturing Principles for Medicines, Active Pharmaceutical Ingredients, and Sunscreens (w.e.f 3 June 2024)

Updated: Apr 16

Australia will be commencing the PIC/S Guide to GMP – 1 February 2022, PE009-16, starting on 3 June 2024, as the manufacturing principles for manufacturing medicines, active pharmaceutical ingredients (API), and sunscreens. However, the principal adoption does not apply to Annexes 4, 5, and 14.

Key changes adopted in the latest guide are:

Annex 13: Updated information and requirements to address issues related to the manufacture of investigational medicinal products

Annex 16: Providing information and requirements of the certification by the authorized person and on the batch release of medicinal products

Manufacturers are advised to ensure the requirements stated in the PIC/S Guide to GMP – 1 February 2022, PE009-16 are relevant to your manufacturing operations. GMP Inspectors are expected to apply the new guide during inspections starting from the commencement date. Hence, it is expected all manufacturers able to comply with the guide and adoption.


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