Die internationale Interdependenz des neuen deutschen Arzneimittelrechts

Zusammenfassung

Am 19. November 1976 ließ das amerikanische Department of Health, Education and Welfare, vertreten durch die Food and Drug Administration, den Entwurf von „Regulations for Good Laboratory Practice” veröffentlichen (1). Diese Good Laboratory Practice Regulations stellen Regeln für die Durchführung nicht-klinischer Laborstudien auf. Der Entwurf dieser Regulations, die inzwischen unter der Abkürzung GLP bekannt sind, stellt eines der großen gegenwärtigen Anliegen der FDA dar. Der FDA Commissioner begründet diesen Verordnungsentwurf wie folgt:

„Recent FDA experiences have identified significant problems in the manner in which nonclinical laboratory studies are being performed. Deficiencies were found during inspections of the testing facüities of major pharmaceutical firms, inspections of several private contract testing facüities, and internal reviews of toxicity studies of color additives conducted by FDA. How widespread or serious the problems are is not known at this time. The agency is concerned, however, that significant deviations in the quality and integrity of reported data might be of a greater magnitude and scope than had previously been assumed.” (2)