Abstract: The European Medicines Agency (EMA) is a decentralised body of the European Union. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The EMA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure).    In 2009 the EMA established a Working Group on third country clinical trials on medicinal products for human use. Reflection Paper on ethical and Good Clinical Practice (GCP) aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA responds to the challenges arising from the increasing globalisation of clinical research. The workshop held on 6-7 September 2010 was part of the consultation process.

Key words: EMA, Clinical trials in third countries, GCP, Ethical  ,  ,  ,  ,