Therapeutic Products regulatory scheme
Joint Agency Establishment Group for the
Australia New Zealand Therapeutic Products Authority
23 May 2006
Consultation begins on proposed Australia New Zealand Therapeutic Products regulatory scheme
The first series of documents detailing the joint regulatory scheme for the proposed new Australia New Zealand Therapeutic Products Authority (ANZTPA) has been released for public consultation.
Submissions are being welcomed on the proposed regulatory scheme or "draft Rules" for medicines, medical devices and administrative matters, along with comments on a discussion paper outlining the proposed arrangements for setting fees and charges to be levied by the Authority.
The ANZTPA establishment group transitional director, Philip Davies, said the joint Authority is being set up to regulate the safety, quality and effectiveness of prescription and over-the-counter medicines, herbal and complementary medicines, medical devices and blood products in both countries.
Once established, it will replace Australia’s Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe).
"Australia and New Zealand have been working together to develop the new Authority since the late 1990s. That work is now beginning to bear fruit in the form of the proposed joint regulatory scheme which will continue protecting the health and well being of New Zealanders and Australians both now and into the future," Mr Davies said.
"The scheme is important to the continued development of closer economic relations between Australia and New Zealand. It will foster trans Tasman trade and will enable our two countries to keep up with international standards for the safety, quality and effectiveness of medicines and products, including blood products and medical devices.
"For consumers, the joint Authority will offer continued reassurance that the medicines and medical devices they use are safe."
The Australian and New Zealand Governments will have equal say in the joint Authority, and a shared responsibility for the way it is run.
Earlier this month, the Therapeutic Products Interim Ministerial Council (New Zealand Minister of State Services, Annette King and the Australian Parliamentary Secretary for Health, Christopher Pyne) announced that the proposed joint regulatory scheme is expected to begin in the second half of 2007.
Before the final commencement date of the joint regulatory scheme can be decided, stakeholder consultations need to be completed and legislation introduced into the parliaments of both countries.
Industry, consumers and other interested groups are therefore invited to have their say in the development of the new Authority's proposed regulatory scheme by making submissions on the following documents:
The draft Medicines Rule: covers the proposed regulatory scheme for prescription and non-prescription (over-the-counter) medicines; and complementary medicines.
A description of the proposed Grouping Order for medicines: describes how medicines with certain shared characteristic can be grouped together on one product licence.
A draft guideline on the transition provisions for product licensing: explains how companies with products already approved by either TGA or Medsafe will be able to obtain an ANZTPA product licence.
The draft Medical Devices Rule: covers the proposed regulatory scheme for medical devices. Examples of medical devices include contact lenses, condoms, heart valves and pace makers, hearing aids, defibrillators and endoscopes.
The key components of the draft Administration Rule: covers the interpretation of Rules and Orders, regulatory definitions and the role of expert advisory committees.
The consultation document on the proposed fees and charges: is a discussion paper which sets out the proposed approach for fees and charges for the work that the ANZTPA will do to assess and approve products such as prescription and over-the-counter medicines, complementary medicines and medical devices for the market.
The closing date for submissions is 15 August 2006.
In addition there are two accompanying resource documents to assist readers with context and 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.
As part of the consultation process a series of industry and stakeholder meetings will be held in Australia and New Zealand during June to discuss the proposed regulatory scheme and the establishment of the new Authority.
Further consultation on the remaining draft Rules and the draft Managing Director’s Orders will begin in September 2006 and March 2007, respectively.
Full details of the stakeholder consultation programme for 2006/07 can be found on the ANZTPA website: http://www.anztpa.org/consult/programme0607.htm
Consultation on the proposed regulatory scheme is not intended to substitute for either country’s formal consultation processes on the proposed legislation. It is anticipated that separate, but aligned Bills, for Australia and New Zealand will be ready for the formal Parliamentary processes around the middle of this year.
"Consulting widely is a key component in the development of the new regulatory scheme," Mr Davies said. "We recognise that some industry sectors will be moving from a lower level of regulation to a greater one, which will deliver benefits for people on both sides of the Tasman who use medicines and medical devices. We will work to support industry through this process."
Copies of the first draft Rules and other supporting documents can be found on the ANZTPA website: http://www.anztpa.org/consult/consdocs1.htm
For media inquiries please contact:
Kay McNiece, (61 2) 6289 5027 Lucy Taylor, (64 4) 819 6882 / (64) 027 207 1406
Questions and Answers
What is ANZTPA?
The Australia New Zealand Therapeutic Products Authority will regulate therapeutic products such as prescription and over-the-counter medicines, complementary medicines, medical devices and blood and blood products in both countries. It will replace Australia's Therapeutic Goods Administration (TGA) and the New Zealand Ministry of Health's Medicines and Medical Devices Authority, Medsafe.
The Authority will be fully funded from fees and charges paid by industry for the evaluation and approval of their products. There will be a three year transition period for products to enable companies to meet new regulatory requirements.
The Australian and New Zealand Governments will have equal say in the new Authority, which will be accountable to both countries. The Authority would have similar accountability to a Crown Owned Entity in New Zealand or a Commonwealth Authority in Australia.
Why a joint Authority?
The joint Authority will help to open the door for greater trans Tasman trade and enhance Closer Economic Relations between Australia and New Zealand. It is also likely to lead to closer cooperation with regulators in the wider Asia-Pacific region. The joint Authority is also a way to ensure both countries are able to continue to provide sustainable regulation which meets international guidelines and recommendations into the future.
The Authority's role is to safeguard public health and safety in both countries through the regulation of the quality, safety and efficacy or performance of therapeutic products. Its work will include pre-market evaluation and assessment; product licensing; controls on manufacture; post-market monitoring and surveillance; and setting standards.
A therapeutic product is one which is used or represented to prevent, diagnose, alleviate, cure or monitor a disease or condition. This includes over the counter medicines; complementary medicines, including dietary supplements and herbal medicines; medical devices such as contact lenses, condoms, hearing aids, heart valves and pace makers and endoscopes. The term also covers blood and blood products, and cellular and tissue therapies. It is important to regulate the safety, quality and effectiveness of these products so that consumers’ health and safety is protected.
What are the different
Phase one of the consultation programme begins in May with the release of the first draft documents outlining the proposed regulatory scheme for medicines and medical devices and the proposed arrangements for fees and charges. Phase two will include consultation on the draft Rules for advertising, blood and blood components and the remainder of draft Administration Rule (including scheduling). It is expected that these documents will be released for consultation in September 2006. The final consultation phase will include draft Managing Director’s Orders which cover topics that have been previously considered by joint interim expert committees, such as the proposed advertising scheme and the proposed labelling scheme.
Advice will be provided at a later date on the timing of the consultation on the regulatory scheme for in-vitro diagnostic devices and for cellular and tissues therapies. There will also be a separate consultation programme for any Australian or New Zealand specific legislation that does not relate to the joint regulatory scheme.
Where does the legislation fit in?
Separate but aligned Therapeutic Products Bills for Australia and New Zealand will be ready for the formal Parliamentary processes around the middle of this year. It is expected that a Bill will be introduced into New Zealand's Parliament in July 2006. Public consultation on the Bill will occur as part of Select Committee scrutiny of the Bill. In Australia an exposure draft of the Australian Bill is expected to be released for consultation in July 2006, prior to introduction to Parliament.
What is the ANZTPA
The Joint Agency Establishment Group (JAEG) was set up in April 2004 and is made up of project team members from Australia's Therapeutic Goods Authority and the New Zealand Ministry of Health Medicines and Medical Devices Safety Authority, Medsafe. This joint establishment project group is overseen by the transitional director, Mr Philip Davies.
Where can I find further
The Australia New Zealand Therapeutic Products Authority website contains the latest information on the project, including frequently asked questions, media releases, consultation information and details about the project. The website is updated regularly and can be found at: http://www.anztpa.org/