Australian law streamlines drug regulatory framework
This article was originally published in SRA
Legislation that aims to strengthen the regulation of therapeutic goods in Australia has been signed into law1. The Therapeutic Goods Amendment (2009 Measures No 1) Act 2009, which received Royal Assent on 27 August, is the second in a series of three acts that were introduced as a package of reforms to streamline the existing regulatory framework2.
The first piece of legislation – the Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 – received Royal Assent on 17 June. A third bill, the Therapeutic Goods Amendment (2009 Measures No 2) Bill 2009, was introduced in the House of Representatives on 24 June.
Provisions in the new law
The Therapeutic Goods Administration has published a brief summary of the key provisions of the Therapeutic Goods Amendment (2009 Measures No 1) Act 2009, some of which came into force on 28 August3. There are varying timelines for other provisions.
From 28 August, for example, it is possible under the new law to temporarily suspend medicines and medical devices from the Australian Register of Therapeutic Goods under certain circumstances instead of fully cancelling them.
Also, it is possible for inspectors monitoring a facility to take video and other recordings, as well as samples of “any thing on those premises that relates to any therapeutic goods”. Other provisions in force include a requirement that medicine labels not make claims that are inconsistent with claims approved for the product.
The following will be enabled within six months:
- manufacturing licences to cover single site, except in certain circumstances, and enabling variation and transfer of licences to other manufacturers;
- the Health Minister able to determine lists of ingredients that are permitted and prohibited to be included in listed medicines. Applications will be able to be made to ask that an ingredient be included in the permitted ingredients list; and
- clarification of the way conditions are set on registered and listed goods.
The effective dates for these measures will be announced in future, says the TGA.
References
1. Therapeutic Goods Amendment (2009 Measures No 1) Act 2009, Act No 76, 2009, 27 August 2009, www.comlaw.gov.au/ComLaw/Legislation/Act1.nsf/0/A51A9CE55A254EF3CA257624001C41E3/$file/0762009.pdf
2. The Regulatory Affairs Journal – Pharma, 2009, 20(8), 517
3. TGA, Second Act to enhance the Therapeutic Goods Act 1989 given Royal Assent, 7 September 2009, www.tga.gov.au/regreform/index.htm#second