The TGA is seeking comments from interested parties on a range of reforms to the regulatory framework for complementary medicines, to address Government-agreed recommendations arising from the Review of Medicines and Medical Devices Regulation.
The consultation discusses:
- A risk-based approach to regulating complementary medicines: three assessment pathways
- Risk-based application categories for pre-market assessment pathways
- Requirements for pre-market submissions
- Business processes for pre-market assessments, and
- Enhancing post-market compliance monitoring scheme for listed medicines.
The Consultation: Business process improvements supporting complementary medicines assessment pathways can be found here.
Those who wish to respond must do so by close of business Tuesday, 7 November 2017. Submissions may address any, or all, of the proposals in the consultation document or other identified issues. An online consultation submission form can be completed to submit a response.
For more information please see the TGA website