Applying for multinational EU trials can be faster via voluntary harmonisation procedure

摘要

Using the voluntary harmonisation procedure to apply for permission to conduct multinational clinical trials across the EU can, in some cases, lead to faster trial authorisations, compared with using the traditional application approach. Even though the VHP was not designed to be quicker than the conventional application route, applicants using the procedure have received final approval to begin their trials, on average, 80 days after making their submission, reported Delphine Decker, director at Voisin Consulting Life Sciences.This compares with overall timelines for approval of anywhere between 28 and 160 (or more) days for applications made via the classical route, Ms Decker told delegates at the Drug Information Association's 24th annual EuroMeeting on 28 March, in Copenhagen. Also, "we've heard that the VHP dossiers are usually given priority at the national level", Ms Decker said during her presentation, in which she revealed that use of the VHP had grown by nearly five-fold and described lessons she had learnt with regard to using the procedure effectively. Ms Decker noted, however; that the 80-day statistic for the VHP does not factor in the time it takes to receive the necessary approvals from ethics committees at the national level, a process that is entirely separate and that can delay receiving a final approval to start a trial in certain countries.