A NEW PRIORITY PATHWAY FOR BIOLOGICALS IN AUSTRALIA: CONTEXTUALISING AND EVALUATING THE PROPOSED REFORMS

This article examines recent reforms to the regulatory framework for biologicals contained in the Therapeutic Goods Act 1989 (Cth) in the context of the New Frontier of reform envisioned in a report completed by the Commonwealth Government in 2021. It compares Australia's proposed reform of the approval processes for biologicals to similar reforms that have been made over the last three decades in the United States and the European Union. It places the Australian reforms in the context of the commercialisation of regenerative medicine and identifies several potential shortcomings of the proposed reforms and reports on the current lack of data on the processes of expedited approvals in Australia more generally.

Automated summary

This article examines recent reforms to the regulatory framework for biologicals in Australia, comparing them to similar reforms in the United States and the European Union. It discusses the proposed reforms in the context of the commercialization of regenerative medicine and highlights potential shortcomings and lack of data on expedited approvals in Australia.