From the National Manager

Three years of change and achievement

This edition of TGA News coincides with my third anniversary as National Manager of the TGA. It has been an exciting time - a period of change and achievement.

One cannot hope in a brief review to mention everything. However, since 1992 we have seen the Baume implementation; the consolidation of the Therapeutic Devices Branch, the Compliance Branch and the TGA Laboratories at the new complex at Symonston; and a period of growth and productivity right across the TGA. A coming highlight will be the introduction of electronic submissions for drug listing applications.

The TGA has taken a leading role in international affairs - participating on the committees of the British Pharmacopoeia and the United States Pharmacopoeia; participating in harmonisation activities associated with the International Committee for Harmonisation (ICH) and the Global Medical Device Conferences; and adopting international standards wherever possible, and appropriate, for drugs and devices.

The performance of the TGA is reviewed twice a year by the Industry Government Consultative Committee (IGCC). This committee has representatives from the peak industry organisations (APMA, PMAA, NFAA, MIAA), together with representatives from the Department of Industry, Science and Technology; and the Department of Finance.

I am very proud of the TGA's performance, which is shown through the quarterly performance reports reviewed by the IGCC and then consolidated in the Department's Annual Report and Statistical Overview.

The enormous increases in productivity over the last three years, the capacity to handle the increased workload, and the maintenance of performance targets is a direct reflection of the contribution made by the staff right across the TGA.

The TGA has established its position as a very highly regarded drug and device regulating body within the developed countries of the world. It has been interesting to note the high regard held of the TGA by other regulatory bodies in the United States, the United Kingdom, Canada, and Sweden. At times I have had the impression that we are more highly regarded overseas than we are at home!

The TGA will continue to maintain its role as a leading regulatory authority, operating within the requirements of the Therapeutic Goods Act and the Therapeutic Goods Regulations, in the interests of providing medicines and medical devices to Australia, and to Australia's export trade, which are safe, effective, reliable, and of high quality.

Two areas of international interest at the present time are proposals to establish mutual recognition agreements with the European Union and New Zealand. These agreements will look at aspects of harmonisation, and mutual recognition, to enhance trade in medical products, but at the same time recognise that medical products are not normal items of commerce.

In the first instance it appears that mutual recognition can best be developed in areas of inspection and licensing of manufacturers, and conformance testing. The harder areas are drug and device evaluation and registration requirements, but these areas, presently under investigation, are important challenges for the future.

This edition of TGA News again brings to your attention matters of current interest across the TGA. I hope you agree that through these, and many other activities, the staff of the TGA do an excellent job; and join me in recognising the contribution that they make to health care in Australia.

Dr Geoff Vaughan