The TGA has published an updated and improved version of the Assessed listed Medicine Evidence Guidelines.
CMA has advocated for scientific improvements and greatly increased clarity, many of which have been implemented in this update. We expect these changes to reduce barriers for sponsors and researchers, make applications easier, and increase the chances of applicant success.
Notable updates that encourage greater confidence in the pathway include:
- Large improvements to scientific interpretations and assessment
- Easier literature-based submissions
- A more user-friendly document.
The TGA are committed to working on further future improvements in consultation with CMA. As always, we welcome your valuable member input.
Please click here for details of improvements!