THE Therapeutic Goods Administration (TGA) presented a Review of Medicines and Medical Devices Regulation (MMDR) to the ARCS (formerly the Association of Regulatory and Clinical Scientists) Webinar on 17 Feb.
Michael Shum, Complementary Medicines Reforms Section, Complementary and OTC Medicines Branch, used a set of 28 slides to presnt the MMDR identifying five streams of work agreed and costed.
Complementary medicine assessment pathways were explained with a commitment to maintain the principle that the level of regulation would be commensurate with the risk.
Specific wording issues around indications were addressed for claims that products "may reduce ...", "help support ...", "may prevent ..." and so forth.
High quality efficacy packages will be required for TGA pre-market assessment and were defined in the presentation.
Visit tga.gov.au for the slide set.
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