Introduction

It is well-recognised that there is a continuous need to monitor the safety of medicines as they are used in clinical practice. Spontaneous reporting schemes (e.g. the UK yellow card system) provide important early warning signals of potential drug hazards and also provide a means of continuous surveillance. Formal studies to evaluate safety mayalso be necessary, par ticularly in the confirmation and characterisation of possible hazards identified at an earlier stage of drug development. Such studiesmayalso be useful in identifying previously unsuspected reactions.

Scope of guidelines

These guidelines apply to the conduct of all company sponsored studies which evaluate the safety of marketed products. They take the place of previous guidelines on post-marketing surveillance which were published in 1988 (BMJ, 296: 399–400). Studies performedunder those guidelines were found to have some notable limitations (BMJ, 1992, 304: 1470–1472) and these new guidelines have been prepared in response to the problems identified. The major changes may be summarised as follows:

1. The scope of the guidelines has been expanded to include all company-sponsored studies which are carried out to evaluate safety of marketed medicines. It should be emphasised that this includes both studies conducted in general practice and in the hospital setting. The name of the guidelines has been changed to reflect the emphasis on safety assessment rather than merely surveillance.

2. […]