Bruno Speder, head clinical regulatory affairs & consultancy, SGS Life Sciences, gives an overview of new EU regulation 536/2014, introduced to provide a single European submission and approval procedure for clinical trials, and discusses the effects it may have on the performance and reporting of early phase clinical trials.
EU regulation 536/2014 has been enacted to provide a new authorisation procedure for clinical trials in Europe. It will enable a single integrated regulatory authority and ethics committee submission for new investigational medicinal products to be made via a single European Medicines Agency submission portal.