THE Therapeutic Goods Administration is seeking feedback on key reforms to the regulation of complementary medicines, with the aim of increasing transparency for consumers, providing additional flexibility for industry and supporting innovation - while maintaining the safety and quality of therapeutic goods in Australia.
The proposals are a response to the government's Review of Medicines and Medical Devices Regulation, and involve the development o f a new three-tiered risk-based framework.
In particular, the plan would introduce a new assessment pathway for CMs, sitting between the existing "listed medicine" (low risk) and "registered medicine" (high risk) pathways.
The consultation also suggest the development of a list of permitted indications which must be used by the lowest risk complementary medicines, while sponsors will be able to claim their medicine has been assessed by the TGA for efficacy, where their product has undergone pre-market assessment by the government agency.
The paper focuses on the implementation of four of the nineteen recommendations from the Review, with these chosen because they would have the most significant impact on reshaping the CM regulatory framework.
The reforms also aim to encourage innovation in the sector, including a two year exclusivity period for newly approved ingredients in listed medicines.
The new assessment pathway for CMs also aims to encourage further research and development.
"If sponsors have supporting data, implementation of a new approval pathway may allow sponsors to have exclusive use of intermediate level indications that fall outside the permissible indications list," the consultation paper suggests.
Feedback is sought by COB on 28 Mar 2017 - see tga.gov.au.
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