Australian therapeutic reforms announced by minister

Posted by Allen Roberts on 21st September 2016

A raft of recommendations to reform Australia’s regulation of medicine and ingredients used in medicinal products has been accepted by the Australian Federal Government.

Minister for Health and Aged Care, Sussan Ley, announced on 15 September 2016 that the government had accepted 56 of the 58 recommendations of the Expert Review of Medicines and Medical Devices Regulation (the Sansom Review).

The Sansom Review was initiated in 2014 to identify areas of inefficiency and duplication in Australia’s therapeutic goods regulation, and to recommend ways that Australian regulation could better respond to global trends.

According to Minister Ley, “bringing medicines into the Australian market quicker will be achieved, in part, by greater use of assessment of medicines by comparable overseas regulators like the US FDA and the European Medicines Agency.”

This will be achieved by allowing greater recognition of approval by foreign regulatory authorities when approving medical products and devices for use in Australia.  The Therapeutic Goods Association (TGA) will also adopt a risk-based approach to variations of medicines.

Key reforms for sponsors of novel foods

The reforms place an emphasis on minimising application times for novel medicines and novel ingredients used in complementary medicinal products. Specifically, the reforms will include:

  • Allowing sponsors of novel ingredients seeking assessment for their use in medicinal products in Australia to submit an evaluation from a comparable foreign regulatory authority, together with the data submitted to the foreign regulatory authority
  • Allowing sponsors seeking registration of medicinal products on the Australian Register of Therapeutic Goods (ARTG) to self-declare or self-assess the safety and quality of the product in certain circumstances. Sponsors seeking to self-assess must also receive an assessment of the efficacy of the product by the TGA
  • Introducing legislative timeframes for assessing new ingredients used in listed medicinal products and publication of finalised compositional guidelines for newly approved ingredients
  • Adoption of a risk-based approach by the TGA to managing variations to medicines and complementary medicines listed in the ARTG
  • Encouraging sponsors to list on their website the evidence used to support indications included on the product
  • Establishing more comprehensive post-market monitoring, including the use of electronic reporting and increased collaboration with foreign regulatory authorities
  • Allowing greater self-regulation in advertising therapeutic goods, but increasing and broadening the enforcement powers of advertising regulators

The Sansom report also recommended a wholesale review of the Therapeutic Goods Act.  The government accepted this recommendation in principle, however, deferred any comprehensive review of the Act until after the effects of the other recommendations are assessed.