Australia’s Therapeutic Goods Administration has issued an update on its overhaul of the regulatory framework for complementary medicines — also known as ‘traditional’ or ‘alternative’ medicines including vitamins, minerals, herbal, aromatherapy and homeopathic products. With these reforms the TGA aims to improve public confidence in the safety and quality of these medicines.
At the moment the regulator is consulting on Part C of the proposed new Australian regulatory guidelines for complementary medicines (ARGCM) regarding evaluation of complementary medicine substances for use in listed medicines. Comments are due by 14 May 2013.
The TGA plans to launch another consultation on the registration process for complementary medicines (Part D) in May/June 2013.
It has already sought public comment on Part A, which provides an overview of the regulatory framework for therapeutic goods in Australia, and Part B, which covers the regulation of ‘low-risk’ complementary medicines. Once all feedback has been received, the ARGCM parts will be consolidated into a final revised document, replacing the existing Parts I-V, which were first published in 2001.
The TGA also held a consultation on permitted (coded) indications, which closed on 15 March 2013.
A table with all the reform timeframes and developments can be found here.