European Medicines Agency publishes reflection paper with practical guidance on the assurance of ethical and GCP standards in the conduct of clinical trials included in marketing authorisation applications submitted in the EU

The European Medicines Agency today published the final 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 (EU)/European Economic Area (EEA) and submitted in marketing authorisation applications to the EU regulatory authorities.

Entering into force on 1 May 2012, the aim of the 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.

Posted on EMA website, 16 April 2012