Evidence Guidelines for Listed Complementary Medicines: Version 4.0
The TGA have finalised and published the updates Evidence Guidelines, Version 4 June 2022; How to demonstrate the efficacy of listed medicines is acceptable. 29 submissions were received to the consultation:
- Industry Groups: 2
- Regulatory agents: 3
- Health care professional groups: 4
- Research/Academic Institutions: 3
- Individuals: 1
- Consumer groups: 0
The TGA have thanked CMA and members for the valuable contribution provided on this mutually important guidance and provided that all feedback has been carefully considered. Further information has been provided by the TGA on the purpose of the guidelines; the legislative basis and expectations; what they consider a critical appraisal, and evidence sources for traditional medicines.
The updated guidelines also make it clear that the guidelines are not mandatory requirements but rather show sponsors what a TGA delegate considers in a compliance review and what will more likely result in a successful compliance review outcome.
Further analysis for members on final outcomes will be published for regulatory and technical staff by CMA technical alert in coming days.
Feedback from members, both now and on an ongoing basis as TGA compliance reviews occur, is strongly welcomed at email@example.com