Industry slowly wakens to benefits of initiative to speed up authorisation of multinational clinical trials in the EU

摘要

While the numbers are still relatively small, there has been an "increasingly rapid build-up" in the number of users of the voluntary harmonisation procedure for multinational clinical trial applications in the EU. Early progress with the procedure has been "very encouraging", according to one senior EU regulator; who says he would "strongly encourage industry to explore and hopefully use this route". The VHP aims to reduce the number of divergent decisions by member state competent authorities on the same multinational clinical trial authorisation application and ensure that trial approval is given simultaneously in a number of member states1'2. Almost 80 applications are expected this yean nearly three times as many as the 27 applications submitted in the whole of 2010. Between March 2009 - when the initiative was launched as a pilot - and December the same year, just 14 applications were received. The VHP has several advantages for sponsors over the traditional route of simply submitting parallel applications in those member states where a company wants to conduct a trial, according to Kent Woods, the chief executive of the UK Medicines and Healthcare products Regulatory Agency. For example, it involves a single application with one set of core documents; it involves fixed timelines; there are no member state-specific requirements; there is a single consolidated set of questions for applicants; and the grounds for non-acceptance in cases going through the VHP have been reduced over the course of the procedure by more than 50%.