Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted outside of the EU/EEA and submitted in marketing authorisation applications to the EU Regulatory Authorities

The European Medicines Agency, on 16 April 2012, 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.

EMA: Press Release: EMA/219517/2012 (16.4.12): Towards a robust global framework for conduct and oversight of clinical trials http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2012/04/WC500125438.pdf

---