The draft Australian Bill implementing the trans-Tasman scheme will be released in July 2006 ready for three phases of consultation.
In the September 2005 edition of Life Sciences Insights (www.claytonutz.com/areas_of_law/controller.asp?aolstring=22&na=991), we looked at the detail of the Therapeutic Goods Advertising Code ("Code 2005") and the implications for sponsors of these changes in the lead-up to implementation of the trans-Tasman scheme. Looking forward, the plan to create a trans-Tasman therapeutic regulatory authority is progressing, with a timeline for the establishment of this authority being released on 27 March 2006. This article will discuss the proposed timeline.
Other recent developments include the formation of a Joint Interim Expert Advisory Committee for Complementary Medicines, announced on 22 March 2006; and the release of the authority's name, the Australia New Zealand Therapeutic Products Authority ("ANZTPA"), in December 2005. Despite this progress, the Authority's commencement date, which was originally planned for 1 July 2006, will be delayed.
ANZTPA will replace the Australian Therapeutic Goods Administration ("TGA") and the New Zealand Medicines and Medical Devices Safety Authority ("Medsafe"), and take charge of these agencies' current regulatory functions. To establish this joint authority, the following instruments are required:
An Australian Bill to implement ANZTPA;
A New Zealand Bill to implement ANZTPA;
A common set of Ministerial Council Rules with detail of the regulatory framework; and
A common set of Managing Director's Orders to define specific technical standards.
The proposed timeline for the introduction of these legal instruments was announced in March 2006 and is outlined below.
July 2006: the Bills are to be introduced
The New Zealand Bill is expected to be introduced to the New Zealand Parliament in July 2006.
A draft of the Australian Bill is expected to be released for consultation in July 2006. It will then be introduced to the Australian Parliament.
May 2006: consultation on the Draft Rules and Orders - the 'first phase'
There will be time for consultation on the draft rules and orders, with the first phase of public consultation commencing later this month. This consultation process will enable the life sciences industry to review and comment on the proposed reforms. The draft rules and orders will be available on ANZTPA's website.
Rules to be released in this first phase include the draft Medicines Rule and Direct Medical Devices Rule, the draft Administration Rule, and the Consultation document on proposed fees and charges. Following this release, a series of stakeholder meetings is scheduled for June 2006.
October 2006: the 'second phase'
The second phase will commence in September 2006 and will allow public consultation of the draft Advertising Rule, the draft Rule for Blood and Blood Components, and the remainder of the draft Administration Rule (including scheduling). Stakeholder meetings are planned for October 2006.
March 2007: the 'third phase'
In the third phase, commencing March 2007, the draft Orders will be released for consultation.
To be confirmed
A consultation period for the regulation of in-vitro diagnostic devices and the regulation of tissues and cellular therapies has not yet been announced.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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