Title: An Overview to Voluntary Harmonization Procedure (VHP)-Approach to Clinical Trial Applications (CTA)
Article Number: EC/2014/028
Authors: Anil Eknath Khedkar
Topic: Clinical Research
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.
You can post and view your comments and reply in full.
Access and participate actively in the open forum, and make your Research visible
Please follow the following steps to participate in Open Forum