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.