Therapeutic Goods Amendment Creates New Regulatory Framework
14 December 2012
The Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009 was introduced into Parliament on November 25, 2009. According to Grant Fisher, a Melbourne-based partner with Blake Dawson, and Felicity Dougherty, a Sydney-based lawyer with Blake Dawson, writing in the firm’s Life Sciences Update, the Bill makes a number of amendments to the Therapeutic Goods Act 1989, in particular relating to the introduction of a new framework for the regulation of biological therapeutic goods. This framework will be set out in a new Part 3-2A in Chapter 3 of the Act. Other matters, such as recall of goods, are also addressed.
In brief, the Bill will introduce a new framework for regulating, specifically, many human cellular and tissue based therapy products. It also introduces the ability to recall specific batches of goods, enables information to be obtained from prior sponsors of therapeutic goods, and amends the immunity for Commonwealth and TGA personnel acting under the therapeutics goods legislation.
“The Bill has been introduced on the basis that the current approach to regulating biological therapeutic goods did not properly reflect the specific nature and production of these therapeutic products,” the lawyers wrote. “The Bill will regulate independently ‘biologicals’ (as defined in the Bill).”
In general, the provisions and offences underlying the regulation of therapeutic goods under the Act will be adapted to, but be consistently applied for, biologicals.
“It is intended that the regulations will prescribe and regulate four classes of biologicals that will be correlated to the relative risk of each biological therapeutic good – there will be different levels of pre market and post-market regulation requirements based on the relative risk of each biological,” they wrote. “It is the intention of the TGA that the framework will exclude assisted reproductive tissues and solid organs, haematopoietic progenitor cells, blood and blood components.”