TGA lays out guidelines on natural medicines registration
the registration of complementary medicines, which are also
expected to form the basis of rules under the controversial joint
agency with New Zealand.
The draft includes requirements for proof of safety, efficacy, quality and the labeling of natural medicines and reflects current requirements in Australia, according to the Therapeutics Goods Administration (TGA).
But it carries new weight following the proposals for a trans-Tasman joint agency, pushed through New Zealand's parliament at the end of the last year. It faced widespread criticism from the dietary supplements industry because it is expected to severely limit the country's range of products and introduce expensive registration costs.
The industry is also concerned that the new agency will be dominated by the TGA, given new powers to deal with supplements last year in the wake of a huge recall of natural products made by a leading Australian manufacturer.
The TGA said there will be further industry consultation on guidelines for the joint agency.
The current draft will be distributed by the Australian Self-Medication Industry (ASMI) and the Complementary Healthcare Council (CHC) to members and is also available on the TGA website. Comments will be received up until Friday 14 May.
