Is the Voluntary Harmonisation Procedure the way forward for multinational clinical trials in the EU?
Hilary Ayshford reports from the recent TOPRA/EMA meeting on how things are progressing. The enlargement of the EU to 27 member states brought with it many procedural complications, not least gaining approval for clinical trials in Europe. Prior to 1 May 2004, there were 15 national approaches, involving a combination of Ethics Committees and Competent Authorities, but after 1 January 2007 there were 27 national approaches with a common minimal basis. Although the clinical trials approval process is defined in a series of Directives and Guidelines, their implementation in national laws has been carried out at different times and taking into account a number of individual factors, such as costs. And even if the application has been submitted in all European countries in parallel, approval remains a national issue, leading to inconsistent decisions and undue delays. For this reason a Voluntary Harmonisation Procedure (VHP) has been put in place. It is a pilot programme that allows a spon
