TGA regulation of medicines & medical devices: Expert review

Edwina Light, writing yesterday in Ethics & Health Law News, drew attention to the recent release of an Australian Government Department of Health discussion paper on the regulation of medicines and medical devices, seeking feedback by 5 January 2015 for a report due 31 March 2015.

The Review will examine the Therapeutic Goods Administration’s regulatory framework and processes with a view to identifying:

  • areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia; and
  • opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.

A chapter on complementary medicines will be released at a later date.