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