The Clinical Trials Directive (2001/20/EC) was agreed by Member States in 2001. Member States were required to transpose the Directive into national legislation by 1 May 2003 and to implement the provisions of the Directive by 1 May 2004. Transposition of the Directive was delayed in the United Kingdom because of concerns expressed by the academic research community about the possible impact on academic research and because of the European Commission's delay in finalising two Commission Directives, one on Good Manufacturing Practice (GMP) and one on Good Clinical Practice (GCP). The GMP Directive was agreed by Member States in 2003. We are committed to implementing the Clinical Trials Directive by 1 May 2004. We are currently finalising our implementing Regulations.