New regulatory pathway for complementary medicines to be operational in 2019

The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017(opens in a new window) passed both houses of parliament with the Senate passing the Bill overnight, legislating the next tranche of reforms recommended by the 2014 Review of Medicines and Medical Devices.

NICM commends the Australian Government on the implementation of such reforms which will strengthen the regulation of therapeutic goods in Australia ensuring the Australian system remains world-class.

A key reform legislated in this latest Bill is the establishment of an additional pathway for the regulation of intermediate-risk medicines.

This amendment will see the two-tiered system for the regulation of all medicines, including complementary medicines, transition to a three-tiered system, and provides a pathway for complementary medicines to have evidence of efficacy assessed by the Therapeutic Goods Administration (TGA).

This change to the regulation of medicines in Australia is an important step as the new pathway will make it easier for consumers to differentiate between complementary medicines that have had evidence of efficacy assessed by an independent assessor – the TGA – and those that have not. The TGA’s positon is in line with the World Health Organisation’s guidelines on the role of traditional and complementary medicine.

The new assessment pathway will sit between the existing listed medicine (low risk) and registered medicine (high risk) pathways, providing sponsors with access to higher level indications than are available on the permitted indications list for low risk medicines.

The three pathways are broadly defined as follows:

  • AUST-L (existing pathway - listed): Listing in the Australian Register of Therapeutic Goods (ARTG) following self-declaration by the sponsor regarding safety, quality and efficacy.
  • AUST-L(A) (new pathway – assessed listed): Listing in the ARTG following self-assessment of the safety and quality and a TGA assessment for efficacy and product label check.
  • AUST-R (existing pathway - registered): Registration in the ARTG following full TGA assessment of safety, quality and efficacy.

A further key reform legislated in this Bill is the introduction of a mechanism providing a level of market exclusivity and protection for sponsors having a new ingredient added to the Therapeutic Goods list of permitted ingredients. It is anticipated this will encourage greater investment in research and development by sponsors.

Read the Bill(opens in a new window) which includes Explanatory Memorandum tabled with the legislation.