In July 2012, the European Commission adopted a proposal for a Regulation on Clinical Trials to resolve a number of problems identified with the current legislation. In the legislative process this proposal is now subject to discussions by the European Parliament and the Council representing the 27 Member States and in parallel by all stakeholders affected by it.One of the key changes proposed concerns the assessment and decision system for clinical trial applications. In the proposal the Commission defines the regulatory environment and the objectives to be achieved. Fulfilling these requirements will need a critical review of the options for national clinical trial approval systems in the Member States and the types of collaboration between competent authorities and research ethics committees. The workshop is meant to provide a platform for a constructive discussion on the ways research ethics committees could be involved and ensure an appropriate ethical assessment of the clinical trials in future.