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There has been a 15% decline in both the number of studies with EU sites and the number of EU subjects participating in these studies between 2007 and 2010, according to Dr Stefan Fuehring, Administrator, DG SANCO, European Commission.
Fuehring was speaking at TOPRA’s (The Organisation for Professionals in Regulatory Affairs) Annual Symposium in Rome last week.
Concerns about Europe’s decreasing competitiveness in clinical research have helped drive recent moves to amend the EU Clinical Trials Directive (2001/20/EC; the ‘Directive’) to make the EU a better environment for clinical research, he said.
The Directive is not the sole reason for decreasing competitiveness, but it is hoped that planned amendments will help reverse the trend and provide a more favourable regulatory environment for clinical research in pharmaceuticals.
The Commission is focusing on four proposals: to use a single electronic portal for CTA submission; to implement a co-ordinated assessment process; adopting a risk-adapted approach; and provision of more detailed guidance for applications, dossiers, and safety reporting.
Efforts have already been made to streamline the current system of separate approvals.
The Voluntary Harmonisation Procedure (VHP) was established in 2009. Its advantages include a fast, single application, said Dr Heiko van der Leyen, CEO, of Hannover Clinical Trial Centre in Germany, but applicants should be aware that the timelines for responses to agency questions are short (10 days), the national applications must be prepared in parallel, and the applications have to be carefully timed in member states where the opinion of the ethics committee needs to be linked to the regulatory approval.
Since the VHP was introduced, Dr Chantal Bélorgey, who chairs the Clinical Trials Facilitation Group (CTFG) and represents Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps), told delegates that there have been 97 VHPs completed, over 50 of which took place in the first 6 months of 2011.
Of note, a significant number of sponsors were small enterprises or non-commercial in nature.
An average of six MSs participated in each procedure, and the average time to VHP opinion for initial CTAs was 50 days, and 20 days for amendments (with the national step following).
All MSs participated in VHPs when requested, with the exception of Poland.
Dr Bélorgey stressed that supporting innovation and clinical trials is a priority for the HMA and, as such, the CTFG supports in general many aspects of the Commission’s current thinking on changes to the Directive.
The proposed changes will provide added value, simplify the procedures, and allow flexibility for sponsors, while also establishing legal support for the activities already being undertaken.