TGA active internationally

TGA staff have recently been involved in two important conferences. The first, in the period 27-29 August, was jointly held by the Association of Regulatory and Clinical Scientists (ARCS) and the TGA.

The ARCS-TGA conference brought together 300 people involved in regulatory affairs to consider issues related to cost efficiency, clinical studies and regulatory affairs, including - for the first time - how these issues relate to over-the-counter products. These annual conferences allow open discussion between regulators and industry, so that the concerns of each party can be discussed in an open forum. The organising committee is looking at ways to further enhance the program and will consider their frequency, location and topics, to increase and promote further avenues for communication.

The second conference, the International Conference on National Medicinal Drug Policies, was co-sponsored by the Australian Government and the World Health Organization (WHO). The conference was held in Sydney, in early October, and brought together 350 delegates from 46 Asian, Pacific, and Indian Ocean rim countries.

The conference developed and endorsed 11 general recommendations relating to national medicinal drug policies. A further 21 recommendations were endorsed in the specific areas of: access to medicine; rational use of drugs; quality, safety and efficacy of medicines; and the industry contribution to national medicinal drug policies and public health goals. These general and specific recommendations will be taken up by the participating countries and will ensure equitable access to, and rational use of, safe and effective drugs of good quality and affordable price in order to improve health outcomes.

Our international involvement continues with our participation in discussions concerning the proposed European Union Mutual Recognition Agreement and the Trans-Tasman Mutual Recognition Arrangement, which are now reaching the final stages of negotiation.

At the national level, Devices Branch is preparing the details for a tracking system for implantable devices and is consulting with interested parties, while the Electronic Lodgement Facility (ELF) for the listing of drug products on the Australian Register of Therapeutic Goods (ARTG) will be fully implemented, following necessary amendments to the Therapeutic Goods Act.

Finally, I am pleased to announce the establishment of "TGA Commercial", a commercial office of the TGA under the direction of Dr Roger Bateman. TGA Commercial will market TGA services on a commercial basis - offering services in the areas of training, contract laboratory testing, quality systems certification, manufacturing plant validation, and off-shore courses for developing countries, as well as offering advice on therapeutic goods regulation policies. The new commercial activities will not interfere with the regulatory roles and responsibilities of the TGA. Rather, they offer new opportunities to market the experience and expertise available within the organisation. The approval to establish TGA Commercial was covered in the 1995-96 Budget process.

Dr Geoff Vaughan