How drugs get to market

Abstract

The Department of Health’s new guidelines for its ‘indicative prescribing’ scheme in general practice1 mean that Family Health Service Authorities (FHSAs) will be encouraging GPs to achieve rational, cost-effective prescribing, especially where prescribing costs have been well above, or well below, average. GPs will get help from various sources including, Prescribing Analyses and Costs (PACT) data and from the new local prescribing advisers, but they will still have to evaluate the many new medicines each year. Because of this, we shall next year publish short notes on new products soon after they are introduced. We will aim to assess evidence cited at their launch, without precluding more detailed review later. It is thus timely to outline the key stages by which a new medicine reaches the market. This article discusses the strengths and some weaknesses of the present system, and the changes foreseen as European Community rules begin to work.