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Experiences With the Approval of Clinical Trials in Germany

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.