The Therapeutic Goods Administration (TGA) is encouraging Australian manufacturers to take part in an international consultation on proposed updates to Good Manufacturing Practice (GMP) guidelines, as the standards move to reflect advances in digital technology and artificial intelligence.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has opened public consultation on revisions to its Guide to GMP for Medicinal Products, with contributions from the European Medicines Agency Inspectors Working Group and input from the TGA.
Key proposed changes include revisions to Chapter 4 on documentation, updates to Annex 11 on computerised systems, and the introduction of a new Annex 22 on artificial intelligence.
The TGA said the consultation is significant for Australian manufacturers because the PIC/S Guide to GMP is embedded in national law under the Therapeutic Goods Act 1989.
“It is the mandated standard for manufacturing therapeutic goods, including active pharmaceutical ingredients and sunscreens intended for human use,” TGA said in a statement.
TGA also noted the guidelines do not apply to blood products, certain cell therapies, or biologicals containing live animal material.
The regulator emphasised the importance of industry feedback, noting that manufacturers will be directly affected by the proposed updates.
Stakeholders, such as industry peak bodies, have been asked to submit responses on behalf of their members, though individual feedback can also be provided directly through the European Commission’s online consultation platform.
Submissions close on 7 October 2025. The TGA stressed that comments should be lodged through the European Commission’s website rather than being submitted directly to the regulator.
