EMEA strategy paper. Acceptance of clinical trials conducted in third countries, for evaluation in marketing authorisation applications

The European Medicines Agency (EMEA), in December 2008, set out its strategy in relation to the acceptance, as part of a marketing-authorisation application, of clinical trials conducted in third countries. The purpose is to reinforce the EMEA’s contribution to assuring that trials carried out in third countries have been conducted in accordance with the required good-clinical-practice and ethical standards.