Good Clinical Practice in the Netherlands: A Gentlemen's Agreement

Abstract

In September 1993, several Dutch organizations involved in clinical drug research and represented in the Dutch Good Clinical Practice (GCP) Committee reached an agreement on their interpretation of the European Community (EC) GCP guideline (III/3976/88 Final) and EC Directive (91/507/EC) in the Netherlands. This “Gentlemen's Agreement” provides explanations and advice on issues that may leave room for multiple interpretations. After explaining how and why the Dutch GCP Committee was founded, the importance of GCP to the different GCP committee members will be discussed. In September 1993 advice and explanations of the Dutch GCP Committee were published. In May 1994 good clinical practice was legalized in the Netherlands.