Medicines

Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products, 1 February 2022, PE-009- 16; (235 page(s), in English)

The Therapeutic Goods Administration (TGA) administers Australia's regulatory framework for the quality, safety, efficacy of therapeutic goods in Australia.

There are provisions under the Therapeutic Goods Act 1989 (the Act) to establish Manufacturing Principles that are to be applied in the manufacture of therapeutic goods. The Therapeutic Goods (Manufacturing Principles) Determination 2020 (the Determination) is the legislative instrument that specifies the manufacture of therapeutic goods must comply with the applicable procedures and requirements in the Pharmaceutical Inspection Co-operation Scheme (PIC/s) Guide to GMP.

As a PIC/S member, Australia is expected to adopt and enforce the latest revisions to the GMP guide to achieve international harmonisation between member countries. Adoption of the PIC/S Guide to GMP as Australia's Manufacturing Principles negates the need for Australian-specific standards, facilitates international trade and supports our international reputation.

The adoption of an internationally harmonised standard minimises regulatory burden for companies involved in the manufacture, import and export of medicines, facilitating trade and helping to ensure the availability of medicines to the Australian public.