COM (2012) 369 is a proposal for a EU regulation on the conduct of clinical trials on medicinal products for human use and provides for the repeal of Directive 2001/20/EC. The number of applications to conduct clinical trials in Europe fell by 25% between 2007 and 2011. The costs of conducting such trials also increased in the same period. The clinical trials Directive 2001/20/EC has been strongly criticised for contributing to delays and increasing the administrative burden. The Commission has, therefore, prepared COM (2012) 369 to provide a regulatory framework to address the shortcomings identified in the 2001 directive. As the proposal is broadly welcomed by the Department of Health, it is proposed it does not warrant further scrutiny, but I suggest the committee write to the Department to ask that it be kept up to date on significant developments. Is that agreed? Agreed.
