The European Commission is seeking views from stakeholders on the rules that should apply to clinical trials in Europe. This is part of the preparatory work being undertaken to review EU clinical trial legislation. The aim of this review is to address shortcomings such as the need to reduce administrative delays, avoid divergent decisions throughout the EU and to streamline reporting procedures.

The current call for stakeholder feedback builds on the 2009/10 public consultation and invites stakeholders to elaborate more on some of the technical issues addressed in the initial consultation. The new consultation document also provides:

· a 'preliminary appraisal' of which option appears to be the most suitable one to

address some of the key concerns of the Clinical Trials Directive, and

· the main figures that are being used to evaluate the impacts of the different policy

options.

Hospital pharmacists involved with clinical trials who wish to share their views on this issue can access the consultation paper via the Commission’s website http://ec.europa.eu/health/files/clinicaltrials/concept_paper_02-2011.pdf

Comments should be provided to the Commission by email sanco-pharmaceuticals@ec.europa.eu no later than 13 May 2011.