The Australia New Zealand Therapeutic Products Authority Newsletter 4

NZ Ministry of Health Web Page
Printed 11/26/2009 05:21:06 PM Back Print

The Australia New Zealand Therapeutic Products Authority Project
Newsletter No 4, November/December 2006

This newsletter aims to provide regular information and updates to New Zealand industry and other stakeholders about the proposal to establish a trans-Tasman regulator for therapeutic products.

Christmas message from the State Services Minister, the Hon Annette King

A milestone was reached last week when the Therapeutic Products and Medicines Bill passed its first reading in the House and was referred to Select Committee where all New Zealanders can have their say.

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, medical devices and complementary health products.

I am excited that the Bill has been supported through to Select Committee despite the attempts of some to deliberately spread misinformation about the proposals.

The new Authority will be the first truly trans-Tasman regulator in which both countries will have an equal voice.

As well as establishing the trans-Tasman regulatory agency, the Bill will also update the medicines legislation to ensure New Zealand retains sustainable regulation for therapeutic products into the future and maintains its regulatory reputation on the world stage.

Importantly, New Zealanders will be given greater assurances about therapeutic products and medical devices they use because the joint scheme will require these products to undergo
pre-market safety approval and licensing and post market surveillance and monitoring.

For industry the proposals will also see trans-Tasman cooperation enhanced and the export of therapeutic products facilitated into Australia and into other overseas markets.

I am committed to supporting the complementary medicines and medical devices sector step into the new scheme. In recognition that these two sectors are making two concurrent changes – into full regulation and into full-cost recovery – the Government is providing a support package of public good funding to provide fees relief and assistance with regulatory compliance for these industry groups.

The proposals are being refined and developed, and in summary provide Government support for 50 percent of the annual charges, which fund post-market safety activities, over a proposed five-year transition period.

This support can continue after the transition period if still needed. The Government is also providing support in the form of regulatory advice to be made available through regulatory support units.

This will include support to assist complementary medicine manufacturers meet Good Manufacturing Practice requirements.

These support units will be set up within Medsafe and will be carried through into the new Authority once it is established.

In addition, work on the Permitted Ingredients List project will continue with further assessments being carried out to look at the safety of ingredients used in complementary medicines.

As you know, the regulatory detail of the proposed joint scheme, or the draft Rules and Orders, is being consulted on separately to the Bill.

This year there has been intensive consultation on the detail of the proposed scheme so that industry, other stakeholders and consumers had the opportunity to help inform the development of the new regulatory scheme.

There will continue to be open minded consultation in 2007, which is crucial in ensuring the proposed new regulatory scheme is workable and meets the overall objective of safeguarding public health and safety in both Australia and New Zealand. As part of the consideration of change proposals put forward in submissions on the proposed joint regulatory scheme, I will be taking a keen interest in the reports on the analysis of submissions.

Thank you to everyone who has taken time to contribute to the ongoing development of this exciting and unique regulatory scheme.

Merry Christmas and I look forward to working with you in 2007 towards the establishment of the new Australia New Zealand Therapeutic Products Authority.

ANZTPA project updates

The Therapeutic Products and Medicines Bill has been introduced into the New Zealand Parliament. Further information, including links to the Minister of State Services media release and to the Bill, can be found under Latest News and Updates on the ANZTPA website.

Information about submissions on the Bill and the closing date can be found on the New Zealand Parliament website.

Information about how to make a submission to a Select Committee is also available on the New Zealand Parliament website.

Consultation on the proposed joint regulatory scheme

Submissions on the phase one consultation (23 May – 15 August 2006)

Good progress has been made on the analysis of the more than 200 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.

Around 225 individual submissions were received, along with a number of generic-style submissions.

Feedback on the submissions will be provided next year.

Phase two consultation (18 October – 6 December 2006)

Submissions closed on 6 December 2006 on 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 requirements.

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.

Further information about the 2006/2007 consultation programme on the proposed joint regulatory scheme is available on the ANZTPA website.

Sign up to receive information about the ANZTPA project in 2007

Stay up to date with the latest ANZTPA project news by registering on-line to receive email updates.

Visit the ANZTPA website for further information on how to subscribe.

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