On January 13, 2025, the Therapeutic Goods Administration (TGA) has announced the adoption of several international scientific guidelines to align Australian regulations with global best practices. The adoption, effective January 2025, aims to enhance the quality and safety of therapeutic goods marketed in Australia. These guidelines complement existing standards and reflect the TGA’s commitment to maintaining stringent regulatory oversight.
Adopted Guidelines
January 13, 2025
- ICH Q3B (R2); CPMP/ICH/2738/99: Impurities in new drug products
- ICH S4; CPMP/ICH/300/95: Duration of chronic toxicity testing in animals (rodent and non-rodent)
- ICH S7A; CPMP/ICH/539/00: Safety pharmacology studies for human pharmaceuticals
- ICH S7B; CPMP/ICH/423/02: Nonclinical evaluation of QT interval prolongation risk in human pharmaceuticals
- ICH S8; CHMP/167235/2004: Immunotoxicity studies for human pharmaceuticals
January 10, 2025
- ICH Q3A (R2); CPMP/ICH/2737/99: Impurities in new drug substances
- ICH Q5B; CPMP/ICH/139/95: Quality of biotechnological products—analysis of expression constructs in cell lines
- ICH Q5D; CPMP/ICH/294/95: Characterization of cell substrates for biotechnological/biological products
- ICH Q6A; CPMP/ICH/367/96: Specifications for chemical substances in new drug products and substances
- ICH Q6B; CPMP/ICH/365/96: Specifications for biotechnological/biological products
January 9, 2025
- EMA/HMPC/201116/2005 Rev. 2; EMA/CVMP/814/00 Rev.2: Quality of herbal medicinal products and traditional herbal medicinal products
What this means for Manufacturers?
The adoption of these guidelines represents a significant step forward in ensuring that therapeutic goods meet the highest global standards. This will impact various areas, including:
- Drug impurity analysis
- Toxicity testing protocols (chronic and nonclinical)
- Safety pharmacology assessments
- Quality specifications for chemical and biotechnological products
- Herbal medicinal product quality
Manufacturers are encouraged to promptly review and integrate these standards into their development and testing processes. This proactive approach will ensure compliance with TGA regulations and support seamless market access.
