Reforms to the regulatory framework for complementary medicines - Assessment pathways

Reforms to the regulatory framework for complementary medicines - Assessment pathways

The Therapeutic Goods Administration (TGA) sought comments from interested parties on a range of reforms to the regulatory framework for complementary medicines to address Government-agreed recommendations from the Review of Medicines and Medical Devices Regulation.
The purpose of this consultation is to provide an opportunity for consumers, health professionals and sponsors to contribute to the development and implementation of a range of reforms aimed to improve the regulation of complementary medicines in Australia. These reforms aim to increase transparency for consumers, provide additional flexibility for industry and support innovation, while maintaining the safety and quality of therapeutic goods available in Australia.

The scope of this consultation includes four elements:

  1. The development of a three-tiered risk-based framework for the regulation of complementary medicines. This will introduce a new assessment pathway sitting between the existing listed medicine (low risk) and registered medicine (high risk) pathways.
  2. The development of a list of permitted indications which must be used by the lowest risk complementary medicines.
  3. Allowing sponsors to claim that their medicine has been assessed by the TGA for efficacy where that medicine has undergone pre-market assessment by the TGA.
  4. Mechanisms to incentivise innovation for the complementary medicines sector.

Submissions will be reviewed by the TGA and feedback will be provided through the TGA website.

>> Read NICM's submission (PDF, 819.83 KB) (opens in a new window)