On 26 February 2001 the Council of the European Union formally adopted a Directive relating to the conduct of clinical trials. On 1 May 2001 the Directive came into force. This new Directive is the first one aimed solely at clinical trials. The rules and regulations governing clinical trials can currently be found in a variety of European and domestic legislation. The new clinical trials Directive seeks to ‘simplify’ and ‘harmonize’ such trials by establishing a ‘clear, transparent procedure’ and by ‘creating conditions conducive to effective co‐ordination of such clinical trials’ by the relevant authorities of each European Member State.