Abstract:

The clinical trial application (CTA) approval in the European Union (EU) member state has been subject to national legislation. Due to this the assessment of a CTA that was filed simultaneously in several EU member states often resulted in varying final decisions and unnecessary delays. Sometimes country-specific modifications to the application often occurred due to changes requested by the different regulatory/competent authorities (RA/CA) and ethics committees (EC). Sometimes a clinical trial might even be approved in one member state and rejected in another. The whole procedure could be extremely time-consuming and the country-specific modifications risk the scientific value of clinical trial results. The Voluntary Harmonisation Procedure (VHP) offers sponsors of multinational clinical trials involving three or more EU member states a harmonised procedure for the regulatory assessment of clinical trial authorisation applications. The Voluntary Harmonisation Procedure makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.

Keywords: Clinical trials, Volutary Hormionsiation Procedure (VHP), Clinical trial application (CTA), Regulatiory authority approval, Europran Union (EU)

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