Good Clinical Practice: EC Expectations Education,Self-Regulation,or Imposition?

Abstract

Within the European Community (EC), an EC guideline currently regulates drug development, which I prefer to call good clinical regulatory practice (GCRP) rather than good clinical practice (GCP). With the increased globalization of the pharmaceutical industry, the European Commission is currently reviewing the guideline, and debating whether to issue a directive. This paper looks at the issues involved. Whatever form the regulation takes, it is hoped that GCP at its best will allow submission of summarized data, facilitating regulation and scientific assessment. EC policy should be centered on patient safety, high-quality research, and developing new medicines.