TGA Reform Bill Hits House Of Representatives

The peak business organisation representing dental product manufacturers and suppliers, the Australian Dental Industry Association (ADIA), has welcomed the introduction of legislation into the parliament that will cut the red-tape associated with bringing new products to the Australian market.

The measures are contained in the Therapeutic Goods Amendment Bill (2017 Measures No 1) Bill (Cth) 2017 that was presented to the House of Representatives by the Minister for Health, the Hon. Greg Hunt MP, on 14 September 2017.

“ADIA has been a strong proponent for reforms that will reduce the time and costs associated with getting TGA market approval for new and innovative patient treatment options. This legislation is a significant step-forward in this area,” said Troy Williams, ADIA Chief Executive Officer.

The Bill provides a pathway that is likely to see medical devices reach the Australian market sooner through the greater use of overseas regulators. Under the amendments, the work of comparable overseas regulators will be accepted as evidence when determining whether a medical device should be included on the Australian Register of Therapeutic Goods (ARTG). Provision of an additional pathway for seeking approval for inclusion in the register provides the potential for faster access to market for industry and therefore earlier access of innovative devices to address specific needs of patients.

ADIA has been a long-standing proponent for these reforms that will deliver a regulatory framework for dental products that is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from an unnecessary regulatory burden.

“The TGA is responsible for administering more than one thousand pages of legislation that impacts small businesses in the dental industry. Much of this legislation is unnecessary as it creates an additional compliance burden without demonstrably enhancing patient safety. The reforms introduced into the parliament yesterday will help reduce compliance costs for business and I commend the efforts of the team within the TGA who worked with us to bring about this outcome” Mr Williams concluded.