Dr Terry Slater, Australia

The Therapeutic Goods Administration (TGA) of Australia is a first-line regulator doing full evaluation of all applications for new medicines. TGA adopts the European standards unless there is a need for a unique Australian standard. Australia encourages the conduct of clinical trials, although the data required for review do not have to be drawn from Australian trials.

Australia is committed to international harmonization. The current Global Harmonization Task Force on Medical Devices is chaired by Australia, and Australia has also held the presidency of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). Australian has adopted many ICH guidelines; but some guidelines have not been adopted because they are not administratively relevant in Australia. Australia develops its own standards only when there is a specific public health need domestically, or where the EU or USA standards do not meet the public health need in that area. Australia’s adoption of global ICH standards means that Australia is able to contribute to global drug development.

ICH guidelines have been used by industry and by the authorities and are of benefit to both. Benefits to industry include decreased time and cost for drug development and a better predictability of outcome. However, the guidelines do impose difficulties on small and new companies.

For the industry and the community, ICH means earlier access to safe and effective products. However, because of the limited coverage of the guidelines, many countries need to consider what factors are important locally, e.g. public health need, special climatic conditions, etc. ICH offers much and delivers much but its full value will only be realized when there is a greater focus on protecting public health.

In conclusion, ICH does not imply individual countries giving up sovereignty over decisions on which products are to be marketed. The acceptance of guidelines in principle does not mean harmonization of drug evaluation or evaluation outcome. Neither does ICH imply mutual recognition of drug evaluation. ICH is not the basis for creating a single decision-maker on whether a drug is safe and effective for the purpose and should be allowed on the entire world market.