Experiences With the Approval of Clinical Trials in Germany: Results of a Survey of Research-Based Pharmaceutical Compan
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Experiences With the Approval of Clinical Trials in Germany : Results of a Survey of Research-Based Pharmaceutical Companies Thorsten Ruppert and Boris Mirko Pfeiffer Drug Information Journal 2012 46: 43 DOI: 10.1177/0092861511429281 The online version of this article can be found at: http://dij.sagepub.com/content/46/1/43
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Clinical Trials
Experiences With the Approval of Clinical Trials in Germany: Results of a Survey of Research-Based Pharmaceutical Companies
Drug Information Journal 46(1) 43-56 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861511429281 http://dij.sagepub.com
Thorsten Ruppert1 and Boris Mirko Pfeiffer2
Abstract The following article presents the results of a survey carried out by the German Association of Research-Based Pharmaceutical Companies (Verband Forschender Arznemittelhersteller; vfa) on the experience of applicants to the competent authorities in Germany with regard to the authorization of clinical trials. Overall the authorization process is assessed positively by the applicants. As in previous years the overall course of the approval procedure in Germany is described as a well-functioning system that is scientifically based and ensures that the assessment is readily comprehensible to the applicant. The ongoing constructive dialogue and exchange of views with the BfArM and the PEI should be used to further improve and harmonize the approval procedure, so that the conditions for trials in Germany may continue at this high level. Furthermore, the article addresses the first experience by German pharmaceutical companies with the so-called "Voluntary Harmonization Procedure" (VHP) on the European level. Keywords clinical trials authorization; competent authorities; Germany; Voluntary Harmonization Procedure
Summary An appropriate and efficient approval procedure for clinical trials is an important factor for the competitiveness of Germany as a location for research. Since the implementation of Directive 2001/20/EU1 as part of the 12th Amendment of the German Medicines Act (12th AMG Amendment)2 in August 2004, approval by the German Federal Higher Authorities—the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI)—is a crucial step before a clinical trial can start in Germany. Hence, the experience of applicants with the approval procedure has a key role in terms of the competitiveness of Germany as a clinical research location. Surveys of the experiences of research-based pharmaceutical com
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