European Regulatory Compliance Issues: Good Research Practices

Abstract

Since the inception of the 1976 Food and Drug Administration (FDA) regulations governing preclinical toxicology, the world has seen an explosion of guidelines, principles, and regulations. The objective of this report is to clarify the situation in Europe as to the status of Good Laboratory Practices (GLPs). An overview of the harmonisation currently underway in Europe is given, although this changes frequently with new countries applying to join the European Community (EC) or undertaking aspects of GLP compliance. Where interactions have occurred between the GLPs and Good Clinical Practices (GCPs) (for example, clinical trials in analyses and bioequivalent studies), the status of clinical pathology and ancillary laboratories is discussed. Finally, particular auditing problems experienced within the EC are addressed. The general concept of GLP has changed very little since the inception of the 1976 FDA regulations governing preclinical toxicology; however, over the past 17 years, several other “good practices” have come into play and, most certainly, the original concept of toxicology and GLP has now been extended into many other scientific areas. Although this text deals primarily with GLP and GCP, the interaction between these two good practices and Good Manufacturing Practice cannot be divorced. The impact of toxicology as a precursor to clinical trials has been seen with the introduction of guidelines for the conduct of such studies. These, with other guidelines for the production of clinical trial materials, mean, in essence, that now the production of a new chemical entity from conception to marketing is completely covered by a series of guidelines and regulations-known colloquially as “the good practices.”