Regulatory Affairs Professionals Society (RAPS) – Asia-Pacific Roundup: Australia’s TGA consults on updated draft companion diagnostics guidance (Catapult’s regulatory round-up – March 2024)
Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on its plans to revise the current guidance on companion diagnostics (CDx), to help companies determine if companion testing is needed and introducing a concept to recognize the diagnostic evaluations carried out as part of a medicine application. The proposed updates aim to provide sponsors and manufacturers of medicines, biologicals and in vitro diagnostic (IVD) medical devices further clarification by providing the following additional sections:
A CDx testing identification guide to assist them in identifying whether their medicine or biological indication requires companion testing,
An introduction to the concept of the ‘companion testing plan’ to recognise the CDx component evaluations undertaken as part of the medicine application.
Improved clarity on clinical and analytical performance requirements for CDx, and
Case studies to assist sponsors of medicines and devices on the regulatory process and the technical documentation required for an IVD CDx.
The draft guidance is open for comment until 17 June. The draft document and information on how to submit comments can be found here.
Published on the 2nd of April 2024 in Catapult’s regulatory round-up for March 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). Regulatory Affairs Professionals Society (RAPS) – Asia-Pacific Roundup: Australia’s TGA consults on updated draft companion diagnostics guidance (Catapult’s regulatory round-up – March 2024). ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/12miz





