TGA News Issue 51 (November 2006) - ANZTPA news
ANZTPA update
In line with the published Stakeholder Consultation Programme 2006/07 <http://www.anztpa.org/consult/programme0607.htm>, the consultation period for the Phase 1 consultation documents (including the draft Rules for medicines and medical devices; a description of the proposed Grouping Order for medicines; draft guidelines on transition provisions for product licensing; the key components of the draft Administration Rule; and the consultation document on the proposed fees and charges) closed on 15 August 2006. The many submissions received from stakeholders are undergoing analysis by officials and a summary of issues arising from the submissions is expected to be published on the ANZTPA website by the end of this year.
Release of the next phase of consultation documents began on 18 October 2006, with comments being sought on a number of documents including the proposed medicines scheduling provisions of the draft Administration Rule and consultation papers on the proposed Product Vigilance arrangements for ANZTPA and the proposed arrangements for the regulation of blood under ANZTPA. The deadline for submissions on these consultation documents is 6 December 2006.
Phase 3 of the Stakeholder Consultation Programme 2006/07 is planned to start in March 2007 and will include the release of drafts of the key Managing Director's Orders for review and comments by stakeholders.
The Australian and the New Zealand Governments are committed to consulting widely as a crucial component in the development of the new regulatory scheme.
More information about the ANZTPA Establishment Project is available on the ANZTPA website <http://www.anztpa.org>.
Trans-Tasman advertising scheme
An Advertising Implementation Steering Group has been established to guide the implementation of the operational aspects of the proposed new regulatory model for advertising of therapeutic products in Australia and New Zealand under the proposed Authority.
The Therapeutic Products Interim Ministerial Council appointed Sue Knowles, former Australian Senator, as Chair of the Steering Group and Tony Miller, Chief Executive of New Zealand's Self-Medication Industry Association as the Deputy Chair.
The Steering Group also comprises key stakeholders groups including consumers, healthcare practitioners (those to whom advertising are directed), the therapeutic products media and advertising industries (those who advertise), and the regulators.
The Steering Group held its first meeting in September 2006, and is anticipated to hold up to three more meetings to assist in putting the new scheme into place. Outcomes from this process will be published on the ANZTPA website <http://www.anztpa.org/advert>.