Consultation - ANZTPA
Submissions sought on proposed Australia New Zealand Therapeutic Products Authority regulatory scheme
23 May 2006
The first series of documents detailing the proposed joint regulatory scheme for the Australia New Zealand Therapeutics Products Authority (ANZTPA) has been released for public consultation today.
The Authority, which will replace Australia’s Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe), will regulate prescription, over-the-counter medicines and complementary medicines, medical devices, along with blood and blood products in both countries.
Details of the proposed regulatory scheme are being released for public consultation in three phases, through a series of consultation documents.
Submissions are being welcomed on the following consultation documents:
the draft Rules for medicines and medical devices; the key components of the
draft Administration Rule; a description of the proposed Grouping Order for
medicines; a draft guideline on the transition provisions for product
licensing; and a consultation document on the proposed fees and charges.
Two accompanying resource documents have also been published to assist readers with context and the interpretation of the consultation documents.
These are: a Plain English Guide on the proposed regulatory scheme for medicines and medical devices, and a document describing the Manufacturing Principles that would apply to manufacturers of therapeutic products under the joint scheme.
Further information, along with copies of these documents, is available on the ANZTPA website: http://www.anztpa.org/consult/consdocs1.htm
The closing date for submissions is 15 August 2006.
In addition, a series of industry and stakeholder meetings will be held in New Zealand and Australia during June to outline the proposed regulatory scheme and the establishment of the Authority.
Further consultation phases on the joint regulatory schemes draft Rules and Orders will begin in September 2006 and March 2007. Information about the consultation phases is also available on the Authority website: http://www.anztpa.org/consult/programme0607.htm
A consultation process for the proposed implementing Bills in each country will be conducted independently of the consultation on the proposed regulatory scheme. It is anticipated that separate, but aligned Bills, for Australia and New Zealand will be ready for the formal consultative and Parliamentary processes around the middle of this year.