Privatsphäre-Einstellungen

Genehmigung von klinischen Prüfungen in Deutschland

Qualitative Erfahrungen mit dem Genehmigungsverfahren für klinische Prüfungen bei den deutschen Bundesoberbehörden / Ergebnisse einer Umfrage bei forschenden Arzneimittelherstellern

Birgit Wolf¹, Dr. Erika Plenz² und Dr. Thorsten Ruppert³

Sanofi-Aventis Deutschland GmbH¹, Berlin, Boehringer Ingelheim Pharma GmbH & Co. KG², Ingelheim, und Verband Forschender Arzneimittelhersteller e. V.³, Berlin

Since the transposition of EU directive 2001/20/EC [1] into the 12th amendment to the German Drug Law (Arzneimittelgesetz) in August 2004 [2], the official approval of a clinical trial by the higher German authorities, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich Institute (PEI), has become an important procedural step that must be completed before the clinical trial can be started. The first surveys on the experiences of research-based pharmaceutical companies with the official approval procedure were performed and published in 2005 and 2006 [3]. On the basis of the experiences recorded in these surveys, a further survey was commissioned to identify any improvements in the quality of the approval procedure at the two higher federal German authorities. In addition to the number of clinical trial applications, the questions of the survey also aimed to determine the type and frequency of deficiencies in or objections to applications.
The number of formal objections with regard to applicants was further reduced compared to the 2006 survey [3]. The frequency of content-related objections tended to remain constant (40% to 50% of applications); most of the BfArM’s objections regarding content related to the trial protocol. With regard to phase IV studies, however, and contrary to the trend in other clinical trial phases, a definite increase was observed in formal objections (69.2 %) and content-related objections (65.4 %) although the application figures for phase IV studies in the past three years have remained constant.
Overall, the comments submitted in this survey demonstrate that the activities of the two higher federal authorities in Germany are rated as positive. The approval procedure in Germany is described overall as a well functioning system. Based on the current survey the applicants identified some issues which might be discussed further with the German authorities e. g. classification of substantial amendments or classification of IMP and NIMP. It was felt that the continued constructive dialogue and exchange of experiences between BfArM, PEI and applicants should be used to further optimize and harmonize the approval procedure.