The Australia New Zealand Therapeutic Products Authority Newsletter 5

The Australia New Zealand Therapeutic Products Authority Project
Newsletter No 5, January - February 2007

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.

Message from the Interim General Manager of Medsafe, Dr Stewart Jessamine

This year promises to be exciting and also busy as we work together towards the further development of the proposed trans Tasman regulatory scheme for therapeutic products.

As many of you may already know, I have recently taken over as the Interim General Manager of Medsafe, replacing David Nicholson who has left to take up the challenge of a new role.

I have been working at Medsafe since 1993 and will be bringing all of the experience I have gained in pharmacovigilance, clinical trials and the regulation of medicines to the challenges of maintaining and improving the effectiveness of Medsafe.

In addition I am committed to ensuring that the operations of the new Australia New Zealand Therapeutic Products Authority (ANZTPA) are as efficient and effective as they need to be for a 21st century regulator.

I would like to take this opportunity to acknowledge the amount of work that many of you have put into making submissions on the detail of the proposed joint regulatory scheme.

The effort you have put into submissions has meant that it has taken officials on both sides of the Tasman, from Medsafe, the Ministry of Health, the Therapeutic Goods Administration (TGA) and the Department of Health and Ageing, time to thoroughly work their way through the comments and suggestions.

The analysis has been largely completed of the more than 200 submissions received on the Phase 1 consultations on the draft Rules for medicines, medical devices and administrative matters, along with the discussion paper on the proposals for fees and charges.

Good progress is being made on the analysis of the 83 submissions received during the Phase 2 consultation 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.

In keeping with our commitment to increased transparency within the new ANZTPA, we will be providing feedback to you on the Phase 1 and 2 consultations in the near future.

I look forward to continuing to work with you during 2007.

Consultation on clinical trials proposals

Submissions are now being invited on a consultation paper outlining the proposed regulatory requirements for clinical trials under the new Australia New Zealand Therapeutic Products Authority (ANZTPA).

Currently New Zealand and Australia apply international standards of Good Clinical Practice (GCP).

While both countries use the same foundation standards, the approval processes for clinical trials do differ in each country, to reflect the underlying legislation and the ethical review systems in each country.

These differences are accommodated under the proposed common ANZTPA scheme.

The proposed model for clinical trial regulation is based on the same risk-management principles that are proposed to apply to the regulation of medicines, medical devices and biologicals.

The closing date for submissions is 18 April 2007.

Further information, including downloadable copies of the consultation paper can be found at: http://www.anztpa.org/consult/clintrials.htm

Submissions welcomed on the draft Advertising Rule

Consultation is currently underway on the draft Advertising Rule which sets out the proposed regulatory requirements under the new ANZTPA for the advertising of therapeutic products.

The draft Rule aims to safeguard public health and safety; protect the public interest; and support the quality use of therapeutic products and informed healthcare choices.

The closing date for submissions on the draft Advertising Rule is 14 March 2007.

Further details about the draft Rule, including downloadable copies and information on how to make a submission is available on the ANZTPA project website at: http://www.anztpa.org/consult/consdocs2a.htm

More detail about the consultation programme

Further information about the 2006/2007 consultation programme on the proposed joint regulatory scheme is available at: http://www.anztpa.org/consult/programme0607.htm

Therapeutic Products and Medicines Bill

Consultation on the Therapeutic Products and Medicines Bill is taking place separately from consultation on the detail of the proposed joint regulatory scheme, the draft Rules and Orders.

The Government Administration Committee called for submissions on the Bill, which closed on 7 February 2007.

Further information about the Select Committee and its process is available on the Parliament website at: www.parliament.nz/en-NZ/SC/Details/GovAdmn/6/a/1/6a1d84d442aa4401ad80555544617df4.htm

Project updates in brief

New staff are being brought on board at Medsafe as part of the development of a complementary medicines support unit and a medical devices support unit. Further updates will be provided as these units and their capabilities are developed.
New and updated fact sheets about the project to establish the new Australia New Zealand Therapeutic Products Authority and proposed joint regulatory scheme are available online at: www.anztpa.org/azguide.htm#f
The Therapeutic Goods Administration is currently consulting on the discussion paper: Improving Access to Consumer Medicine Information (CMI) and Product Information (PI). New Zealand stakeholders are also invited to make submissions on the paper.

Further details are available at: www.anztpa.org/pm/accesspmi2.htm

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Visit the ANZTPA project website (http://www.anztpa.org/new/anztpa-update-subscribe.asp) for further information about how to subscribe to the list server email updates.

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