This paper describes the use of data about the effects of medicinal drugs on driving that are submitted by applicants for product licensing in the European Union. Existing European guidelines and directives are discussed in order to illustrate the need to review the requirements of data pertaining to the effects of psychotropic drugs on driving. The impact of results from experimental human psychopharmacological research on these guidelines and directives is reviewed briefly to show that some progress has been achieved in improving regulatory processes. Specific interest is focused on the graded warning system that can appear on official package inserts and which was adopted by the Committee for Proprietary Medicinal Products in 1991. This paper concludes with a discussion of ways by which regulatory authorities can implement an improved warning system for patients who are likely to engage in potentially dangerous activities like driving. (A)
Samenvatting