Submission to the Therapeutic Goods Administration on the regulatory framework for advertising therapeutic goods


Date: 22 December 2016

In September 2016, the Australian Government accepted a number of recommendations for reform of the regulatory framework for advertising therapeutic goods made by their Expert Review of Medicines and Medical Devices Regulation panel in 2015. In brief, these recommendations included:

  • ceasing pre-approval of advertisements in favour of an industry self-regulation approach
  • implementing a more transparent and efficient complaints management process
  • establishing greater consistency around regulating advertisements for different types of therapeutic goods
  • implementing an education program for industry organisations
  • broadening the powers of the Therapeutic Goods Administration (TGA) in investigation and enforcement.

The TGA invited submissions on the proposed reforms in November 2016.

The RACGP has provided feedback which indicates support for many of the reforms, with the exception of the plan to replace the current system of vetting and pre-approving advertisements with an industry self-regulation approach