28/05/2010 - The European Medicines Agency is inviting public comments on its 'Reflection paper on ethical and GCP aspects of clinical trials conducted in third countries for evaluation in marketing authorisation applications for medicines for human use, submitted to the EMA'.
The reflection paper is part of the Agency's overall strategy on the acceptance of clinical trials conducted in third countries. Highlighting the need for cooperation between international regulatory authorities, the paper proposes a series of measures to ensure a robust framework for the oversight and conduct of clinical trials, no matter where in the world investigators' sites are located and patients are recruited.
Comments on the reflection paper should be submitted by 30 September 2010 using the Agency's comments template. As part of the public consultation process the Agency will hold a workshop to review and discuss comments on 6-7 September 2010. Invitations to this event will be sent out shortly.