The TGA has published an updated web page on Guidance on using evaluation reports from Comparable Overseas Bodies (COB). The changes to this guidance affect eligible:
- New substance (or changed substance) applications for the Permissible Ingredients Determination
- AUST L(A) applications
- AUST R complementary medicine applications.
Today’s full alert includes a summary of all key changes to the guidance as well as a comparison table of the 2022 list and the newly published 2023 list of COBs which outlines any changes or additions.
New COB Checklists are also published to accompany the updated guidance.