TGA News Issue 52 (March 2007) - ANZTPA update

Phase 2 of the Stakeholder Consultation Programme 2006/07 <http://www.anztpa.org/consult/consdocs2.htm> began on 18 October 2006, with the release 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 was 6 December 2006. Following the release of these documents, focus group workshops were held in Australia and New Zealand during November 2006.

The Draft Advertising Rule <http://www.anztpa.org/consult/consdocs2a.htm> was released for consultation on 17 January 2007. The closing date for submissions was 14 March 2007. Key stakeholder groups were invited to focus group meetings which were held in Australia and New Zealand during February 2007.

The consultation paper: Proposed clinical trial regulatory arrangements under the Australia New Zealand Therapeutic Products Authority (ANZTPA) <http://www.anztpa.org/consult/clintrials.htm> was released for stakeholder feedback on 21 February 2007. Written submissions have been sought and the closing date for submissions is 18 April 2007.

In the lead up to the establishment of ANZTPA, the stakeholder consultation process will continue as consultation documents on in-vitro diagnostic devices (IVDs), human cellular and tissue therapies (HCTs) and new Managing Director's Orders (MDOs) are developed and released for stakeholder feedback.

All consultation documents will be published on the ANZTPA website and written submissions invited. Where appropriate, the release of consultation documents will be supported by targeted stakeholder focus group meetings.

Because of the large number of consultation documents relating to Managing Director's Orders (MDOs), a webpage will be created to provide a central place for links to these documents. Stakeholders are encouraged to regularly visit the page: <http://www.anztpa.org/consult/mdos.htm>, which will include links to all draft MDOs as they are released for stakeholder consultation.

More information about the ANZTPA Establishment Project is available on the ANZTPA website <http://www.anztpa.org>.