Message from the Transitional Director
An update on progress towards ANZTPA
21 December 2006
This email was sent to ANZTPA-UPDATE email list subscribers on 21 December 2006.
Dear Sir / Madam
Thank you to all of you who have taken time to comment on the proposed joint regulatory scheme under the Australia New Zealand Therapeutic Products Authority (ANZTPA).
This year has seen an intensive period of consultation undertaken as part of the development of the draft Rules and Orders.
Good progress has been made on the analysis of the 225 submissions received on the draft Rules for medicines, medical devices and administrative matters, along with the discussion paper on the proposals for fees and charges.
Feedback on the submissions will be provided next year.
Submissions have also now closed on three further documents: the proposed medicines scheduling provisions of the draft Administration and Interpretation Rule; the consultation paper on the proposed regulation of blood under the ANZTPA; and the consultation paper on the proposed product vigilance arrangements.
The submissions will be analysed by officials from New Zealand's Medsafe and Ministry of Health and Australia's Therapeutic Goods Administration and its Department of Health and Ageing. An update about the progress of the analysis work will be provided in early 2007.
In addition the New Zealand Therapeutic Products and Medicines Bill was recently introduced into the New Zealand Parliament and was referred to Select Committee.
This is a significant step towards the establishment of a world-class trans-Tasman regulatory scheme that will provide better health and safety protections for consumers who use medicines and medical devices.
Further information about the Therapeutic Products and Medicines Bill is available at the New Zealand Parliament Website [http://www.parliament.nz/en-NZ/PB/Legislation/Bills/1/5/8/158f6594b0e74acf89fee18dd11c0f92.htm].
In Australia, a separate Therapeutic Products Bill will be released as an exposure draft for consultation, prior to introduction into the Australian Parliament.
Consultation on the proposed joint regulatory scheme, or the draft Rules and Orders, will continue during 2007.
Thank you again to all of you who have taken time to participate in the consultation processes during 2006.
We look forward to continuing to work with you next year.
Merry Christmas and best wishes,
Philip Davies
Transitional Director
Australia New Zealand Therapeutic Products Authority Establishment Project
URL: http://www.anztpa.org/new/anztpa-update/2006/061221transit-direct.htm