THE Therapeutic Goods Administration (TGA) is seeking feedback on a number of proposed reforms that it says will "deliver a more flexible, predictable, efficient and transparent regulatory framework for complementary medicines (CMs)".
There are five key issues on which the TGA seeks input:
1. The introduction of risk-based application categories for pre-market assessments
2. Proposed application requirements, business processes, legislated assessment timeframes and fee structure for applications in each category
3. A set of minimum data requirements to standardise complementary medicine pre-market assessments
4. Criteria and mechanisms for acceptance of reports from comparable overseas regulators and alternate sources of evidence for de novo assessments
5. Strategies to enhance the post-market monitoring and compliance scheme for listed medicines.
The TGA also points out that while it has consulted previously on the proposed use of evaluation reports from comparable overseas regulators for prescription medicines and medical devices, this consultation focuses on complementary medicines only.
Visit tga.gov.au for access.
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