Articles

We will implement process enhancements to the Prescription Medicines Minor Variation (PMMV) form by 31 January 2026.

The International Medical Device Regulators Forum (IMDRF) Software as a Medical Device (SaMD) Working Group has published the draft Essential Principles and Content of Predetermined Change Control Plans document for public consultation.

The TGA is updating information for nitrosamine impurities and other nitroso-structure impurities in medicines including acceptable intakes (AI).

There is growing interest in using software and artificial intelligence (AI) in healthcare settings, including where it is used to support people with mental health conditions.

The GMP Guidelines on Chapter 1 - Pharmaceutical Quality System are being updated to reflect contemporary Quality Risk Management principles and further improve how Product Quality reviews are performed.

A review of the GMP Clearance backlog reduction strategies that have been implemented and ongoing monitoring and reporting communication.

Instructions for searching Australian manufacturers licensed for the manufacture of medicines, blood and biologicals.

Know how we manage compliance of AI and software products that meet the definition of a medical device.

From 1 September 2025, the TGA will adopt an updated version of the PIC/S Guide to GMP (PE009-17), with changes focused on Annex 1 for sterile medicines, and a phased compliance approach for manufacturers.

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

The GMP Clearance SID now contains additional data as well as progress information on the Compliance Verification (CV) backlog reduction strategy.

The TGA is updating information for nitrosamine impurities and other nitroso-structure impurities in medicines including acceptable intakes (AI).

Information on the completion of automatic extensions for Good Manufacturing Practice (GMP) clearances and next steps.

Temporary risk-based strategies to expedite the reduction of the GMP Clearance Compliance Verification (CV) backlog commences today.

The TGA has accepted a court-enforceable undertaking from The Aussie Gelatin Company Pty Ltd (Aussie Gelatin) in relation to the alleged unlawful manufacture, supply and advertising of therapeutic goods.

We have accepted a court-enforceable undertaking from The Aussie Gelatin Company Pty Ltd (Aussie Gelatin) in relation to the alleged unlawful manufacture, supply and advertising of therapeutic goods.

Temporary risk-based strategies are being introduced to expedite the reduction of the Good Manufacturing Practice (GMP) Clearance Compliance Verification (CV) backlog.

Our Good Manufacturing Practice (GMP) Clearance information resources have been updated with new information for Sponsors

Updated information for nitrosamine impurities in medicines consistent with recent EMA updated information.

We have issued 4 infringement notices totalling $75,120 to Queensland based pharmacy Summit Pharmacy Pty Ltd, for the alleged unlawful manufacturing of medicinal cannabis products.

Update on the progress in reducing the backlog of GMP Clearance Compliance Verification (CV) applications.

The updated plan emphasises solidifying our collaborative processes, aligning expectations with industry, and improving our communication strategies.

This consent is given under sections 14 and 14A of the Therapeutic Goods Act 1989.

MRA GMP clearances that are expiring on 31 December 2024 will be automatically extended.

The TGA is updating information for nitrosamine impurities in medicines including acceptable intakes (AI).