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Proposed Australian and New Zealand Therapeutic Products Authority Regulatory Scheme

In brief: Patent attorney, Dr Kathryn Sunn, provides an outline of the first of three consultation phases on the proposed joint therapeutic products regulatory regime for Australia and New Zealand.

In December 2003, the Australian and New Zealand Governments agreed to establish a joint agency and regulatory scheme for therapeutic products. The new agency is to be called the Australia New Zealand Therapeutic Products Authority (ANZTPA).

On 23 May 2006, the first series of consultation documents detailing the proposed joint regulatory scheme for ANZTPA were released for public consideration. ANZTPA, which will replace Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe), will regulate prescription, over-the-counter medicines and complementary medicines, medical devices, along with blood and blood products in both countries with the aim of protecting the health and safety of Australians and New Zealanders through jointly regulating therapeutic products in accordance with international best practice. During the consultation period, meetings will be arranged with key stakeholders to provide an opportunity for officials to outline the regulatory scheme proposals, answer questions and receive preliminary feedback.

The New Zealand implementing legislation (Therapeutic Products Bill) is expected to be introduced to the New Zealand Parliament in July 2006. Consultation on the Bill will occur as part of the Parliamentary process during Select Committee consideration of the Bill. An exposure draft of the Australian Bill is expected to be released for consultation in July 2006, prior to introduction to the Australian Parliament.

Details of the proposed regulatory scheme are being released for public consultation in three phases through a series of consultation documents. 

Phase one includes draft Medicines Rule, Draft Medical Devices Rule, key components of Draft Administration Rule and consultation documents on proposed fees and charges. Public consultation will be sought over a three -month period commencing late May 2006.

Phase two includes Draft Advertising Rule, Draft Rule for Blood & Blood Components Remainder of Draft Administration Rule (including scheduling). Public consultation will be sought over a six-week period commencing mid-September 2006.

Phase three includes Draft Orders and public consultation will be sought over a six-week period commencing March 2007.

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Phase One

Draft Medicines Rule

This draft Rule covers the proposed regulatory scheme for prescription and over-the-counter medicines and complementary medicines and includes:

  • The approval processes and authorisation requirements to licence a medicine.
  • The licensing requirements for medicine manufacturers.
  • Exemptions where no licence would be required.
  • The requirements for medicine recalls.
  • Description of the Proposed Grouping Order for Medicines

The Grouping Order describes how medicines with certain shared characteristics can be grouped together on one product licence and, when finalised, would sit underneath the Medicines Rule.

Draft Guideline on Transition Provisions for Product Licensing

The draft Guideline describes how therapeutic products that are lawfully being supplied in Australia or New Zealand will be issued with an interim licence for 3-years enabling products to continue to be sold during the initial 3-year transition period. The draft transition guideline also describes the transition process for obtaining an ANZTPA product licence that would authorise therapeutic product supply in both Australia and New Zealand.

The draft guideline for transition to the joint regulatory scheme covers:

  • Class 1 medicines (most complementary medicines).
  • Class 2 medicines (prescription and over-the-counter (OTC) medicines).
  • Medical Devices.
Draft Medical Devices Rule

This draft Rule covers the proposed regulatory scheme for medical devices including:

  • The essential principals and medical device standards.
  • Conformity assessment for medical devices.
  • The requirements for the manufacture of medical devices.
  • Medical devices product approval and licensing.
  • Products that are exempt from certain requirements.
  • Product recalls.
Draft Administration Rule

Key components of this draft Rule include:

  • The proposed establishment and role of expert advisory committees which would provide advice to the ANZTPA.
  • The inspection of premises where therapeutic products are manufactured or sold including factories or business premises.
  • The proposed scheduling framework for medicines.
Consultation Document on Proposed Fees and Charges

This discussion paper sets out the approach for proposed fees and charges including:

  • The policy objectives for cost recovery.
  • The cost base for the ANZTPA.
  • Details of the fees and charges proposals and seeks views on fee options for potential impacts.

Written submissions are invited on the phase one consultation documents and the closing date for submissions is 15 August 2006.

Further information, along with copies of these documents, are available on the ANZTPA website.

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