TGA opens consultation on reforms to complementary medicine regulatory framework

Posted by Andrea Hogan on 2nd October 2017

The Therapeutic Goods Administration is seeking comment on reforms to the regulatory framework for complementary medicines.

The Therapeutic Goods Administration (TGA) said the purpose of the consultation is to provide an opportunity for consumers, health professionals and sponsors to contribute to the development and implementation of a range of business processes aimed at improving the regulation of complementary medicines in Australia.

“These reforms aim to ensure timely access to high quality, safe and effective complementary medicines for consumers and greater flexibility and efficiency in the evaluation process for industry, while ensuring an appropriate level of risk is applied to the evaluation of complementary medicines,” the TGA stated.

The consultation includes five elements including:

  • Business processes to support the introduction of a three-tiered risk-based framework for the regulation of complementary medicines, with a new assessment pathway sitting between the existing listed medicine (low risk) and registered medicine (higher risk) pathways.
  • Use of reports from comparable overseas regulators for the assessment of new ingredients, new registered medicines and products assessed through the new listing pathway.
  • Broadening the range of acceptable sources of evidence for the assessment of ingredients proposed for use in listed medicines.
  • Introduction of legislated timeframes and a new fee structure for complementary medicine and ingredient assessments.
  • Enhancing the post-market compliance monitoring scheme for listed complementary medicines.

The consultation has been initiated after in March 2015 an Expert Panel conducted a review of medicines and medical devices regulation and made 19 recommendations to improve the regulatory controls for complementary medicines manufactured, supplied and/or exported from Australia.

The five elements of the consultation are five of the nineteen recommendations from the review.

Submissions are now open and should be submitted to the TGA by Tuesday 7 November 2017.