Establishment of trans Tasman agency gains momentum

The establishment of the new joint therapeutic products agency (the Agency), which will replace Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe), gains momentum as key issues are negotiated and agreed between Australia and New Zealand on regulatory arrangements for the Agency.

To facilitate the establishment of the joint scheme for the regulation of therapeutic products, a Therapeutic Products Interim Ministerial Council, comprising the New Zealand Minister of Health, Annette King, and the Australian Parliamentary Secretary for Health, Trish Worth, has been established. The Interim Ministerial Council had its inaugural meeting on 12 December 2003 in Wellington, New Zealand, and has had four subsequent meetings. All decisions of the Interim Ministerial Council require the agreement of both Council members.

The Council recently announced that agreement had been reached to include the regulation of blood <http://www.anztpa.org/media/040510tpimc.htm> in the Agency's responsibilities. Both Ministers agreed that there would be significant benefits to be gained by a joint regulator of blood, blood components and blood products. For example, potential safety problems can be more effectively monitored, detected and addressed and safety enhancements can be developed and implemented more readily.

Agreement has also been reached between Australia and New Zealand to identify and coordinate reviews of labelling requirements for medicines <http://www.anztpa.org/media/040601tpimc.htm> and to develop and implement the requirements in both countries. Common labelling requirements will have benefits for consumers and industry in both countries. Ms King and Ms Worth agreed that this is a positive step both for consumers and the medicines industry.

There are a number of activities currently underway within the TGA and Medsafe that may impact on labelling requirements for medicines under the Agency. Ms King and Ms Worth agreed that those activities now near completion should be coordinated, consolidated and continued as part of the development of trans Tasman labelling requirements, including the development of a draft Trans Tasman Labelling Order for consultation and finalisation in Australia and New Zealand prior to 1 July 2005. The joint scheme will result in benefits to industry, as there will be a single set of regulatory requirements, such as labelling, for both markets.

Ms King and Ms Worth have also approved the creation of a joint agency establishment group to manage the Australian and New Zealand staff responsible for setting up the Agency. This group will bring together the work of the two project teams - one in Australia and the other in New Zealand - achieving a more streamlined joint working arrangement to ensure that work proceeds in the most efficient and cost effective manner.

Increased monitoring of sponsors to ensure compliance with conditions of registration / listing in the ARTG

Following the Pan recall in April 2003, the therapeutic goods legislation was amended to provide increased legislative powers in relation to manufacturers and sponsors. In the case of sponsors, the legislative changes included powers related to:

• notification of all manufacturers and manufacturing sites to the TGA;
• maintenance of records of products supplied and their manufacturers, and to have these records available at any time for inspection;
• requirements for sponsors to publish manufacturing details of recalled goods;
• previously cancelled medicines cannot be automatically re-listed under ELF;
• "unacceptable presentation" includes identification;
• false statements in applications for marketing approval;
• notifying the TGA of any change of manufacturer; and
• improved reporting of adverse events.

While the TGA currently seeks information from sponsors concerning data that they hold, there is to be an increased focus in this area in the future to ensure that sponsors are continuing to meet their obligations and are complying with the relevant regulatory requirements.

Checks undertaken may include:

• that listing/registration conditions are met, for example
  • records of distribution;
  • records of stability data to justify shelf life conditions;
  • mechanisms for recording and reporting problem reports, adverse reactions, etc;
  • mechanisms for preventing supply of medicines that have expired;
• that sponsors hold up-to-date records of contract manufacturers used to manufacture specific products;
• that current copies of GMP agreements are held for all contract manufacturers used;
• where the GMP agreement specifies that the sponsor is responsible for manufacturing steps such as stability testing, the TGA will check that stability testing has in fact been conducted;
• that a copy of the marketing authorisation is held;
• that the product formulation, method of manufacture, label details, etc match what has been approved by the TGA for registered products; and
• evidence of SPF factor testing for sunscreen products.

For more information on the May 2003 legislative amendments relating to sponsors see: Amendments to the Therapeutic Goods Act 1989 (May 2004) <http://www.tga.gov.au/legis/tgaa0301.htm>