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
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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
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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
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What the New Chapter 4 Means for GMP Documentation

What the New Chapter 4 Means for GMP Documentation

Quality Systems Now
Published on: 27/08/2025

What the New Chapter 4 Means for GMP Documentation

NewsGMP
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