Have your say on updates to Good Manufacturing Practice (GMP) Guidelines

As digital technology and Artificial Intelligence (AI) transform medicine manufacturing, the GMP guidelines are being updated to ensure they remain current and effective.

Public consultation now open

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has launched a public consultation on proposed revisions to its ‘Guide to GMP for Medicinal Products’. Key updates include:

• Revised Chapter 4: Documentation
• Revised Annex 11: Computerised Systems
• New Annex 22: Artificial intelligence.

These updates have been developed by a joint PIC/S and European Medicines Agency Inspectors Working Group, with input from the Therapeutic Goods Administration (TGA). More information is available in the PIC/S news article.

Why these updates matter to you

If you’re an Australian manufacturer affected by these updates, your input is important. The PIC/S Guide to GMP is embedded in Australian 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. It does not apply to blood products, certain cell therapies, or biologicals containing live animal material.

How to respond

If you belong to a stakeholder organisation (e.g Industry peak body), PIC/S have requested that feedback is submitted through your stakeholder organisation.

You can also provide feedback directly using the survey tool on the European Commission website.

Consultation closes on 7 October 2025. It’s important to make your submission through the Commission’s website and not to the TGA.