Trans-Tasman Agency
This article was originally published in RAJ Devices
Executive Summary
Phase one consultation documents published
Phase one consultation documents published
The first phase of public consultations on the proposed new Australia New Zealand Therapeutic Products Authority has begun with the release of six consultation documents, including the draft medical devices rule and a draft guideline on transition provisions for product licensing. The closing date for all submissions is
15 August 2006.
The draft medical devices rule covers the proposed regulatory scheme for medical devices1,2. It outlines the essential principles and medical device standards, conformity assessment, the requirements for the manufacture of medical devices, device product approval and licensing, outlines which products are exempt from certain requirements and details the process of product recalls.
The Therapeutic Products Interim Medical Council recently confirmed that there would be a three-year transition period to allow industry and consumers to adapt to changes in the system. The draft guideline on transition describes how therapeutic products, which are lawfully being supplied in Australia or New Zealand, will be issued with an interim three-year licence which will enable products to be sold during the transition period. Additionally it outlines the transition process for obtaining an ANZTPA product licence that would authorise product supply in both countries. The draft transition code applies to all medical devices as well as to complementary, prescription and over-the-counter medicines.
The other documents released for consultation are: a description of the proposed grouping order of medicines; the draft medicines rule; the key components of the draft administration rule; and the consultation document on the proposed fees and charges. All documents can be downloaded from the ANZTPA website at http://www.anztpa.org/consult/consdocs1.htm.
Two more consultation phases are due to take place with the second in September 2006 scheduled to include the draft rules for advertising, blood and blood components3. Consultation on the managing director's orders will take place during phase three in March 2007.
Start date for agency
The Australian and New Zealand governments expect the proposed agency to begin operations in the second half of 20074. Stakeholders will be given at least six months notice prior to the commencement date, which will follow a round of industry and public consultations and the introduction of legislation in both countries. In a statement, a New Zealand government official said “Doing it properly is one of the main reasons establishing the authority has taken longer than we had initially hoped.”
References
1. ANZTPA press release, 23 May 2006, www.anztpa.org/media/060523cons.htm
2. ANZTPA consultation documents, 23 May 2006, www.anztpa.org/consult/consdocs1.htm
3. The Regulatory Affairs Journal - Devices, 2006, 14(3), 158-159
4. Therapeutic Products Interim Ministerial Council press release, 11 May 2006, www.tgamedsafe.org/media/060511tpimc.htm