AusBiotech 2025 International Conference

AusBiotech 2025 International Conference

Quality Systems Now
Published on: 01/12/2025

AusBiotech 2025 offered a valuable reflection point for the biotechnology sector, particularly regarding GMP and regulatory compliance.

NewsGMP
Temporary GMP Exemptions for Bacteriophage Therapies in Australia

Temporary GMP Exemptions for Bacteriophage Therapies in Australia

Quality Systems Now
Published on: 02/11/2025

The proposed temporary GMP exemption by the TGA for personalised bacteriophage therapy manufacture in Australia marks a significant regulatory development for the emerging phage‑therapy sector.

News
New Regulations to Strengthen Medical Device Patient Safety

New Regulations to Strengthen Medical Device Patient Safety

Quality Systems Now
Published on: 26/10/2025

The introduction of mandatory reporting requirements for medical device-related adverse events marks a significant step forward in enhancing patient safety in Australia.

News
Understanding the Therapeutic Goods Legislation Amendment Effective from 1 October 2025

Understanding the Therapeutic Goods Legislation Amendment Effective from 1 October 2025

Quality Systems Now
Published on: 13/10/2025

Understanding the Therapeutic Goods Legislation Amendment Effective from 1 October 2025

Therapeutic Goods Administration News