The final reflection paper on ethical and good clinical practice (GCP) published by the European Medicines Agency has as main aim to strengthen existing processes to provide assurance to regulators and stakeholders that clinical trials meet the required ethical and GCP standards.

The European Medicines Agency published a reflection paper on ethical and good clinical practice (GCP) aspects of clinical trials of medicinal products for human use conducted outside of the European Union and submitted in marketing authorisation applications to the EU regulatory authorities. Clinical trials carried out in countries outside EU Member States and submitted in marketing authorisation applications to EU regulatory authorities are expected to meet ethical principles and standards equivalent to those applied to clinical trials performed within the EU. Recently, European regulators also examined the reasons for and against the open access of the results of clinical trials.

In particular, the aim of this paper is to strengthen existing processes to provide assurance to regulators and stakeholders that clinical trials meet the required ethical and GCP standards, no matter where in the world they have been conducted. The paper puts forward concrete steps for international cooperation in the regulation of clinical trials, with a specific emphasis on capacity-building initiatives for a common approach to oversight of trials. Moreover, it clarifies and determines the practical steps by which EU regulators will gain assurance that ethical and GCP standards are applied to clinical trials for human medicines, both during the development and during the marketing-authorisation-application phase.

In addition, the reflection paper emphasises the role of independent local ethics committees in the oversight of clinical trials and stresses the importance of obtaining trial subjects’ consent. It discusses key issues including those arising from the comparator used in a trial (active or placebo) or access to treatment after a trial, especially in the context of the vulnerability of trial subjects.