European Medicines Agency public consultation on ethical and good clinical practice (GCP) aspects of clinical trials conducted in third countries

The European Medicines Agency has published a draft 'Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA'.

The document is available on the following webpage:

http://www.ema.europa.eu/Inspections/docs/71239709en.pdf
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.

Your comments on this reflection paper are most welcomed by 30 September 2010 to the address ctrefpaper@ema.europa.eu.

Please kindly use the template in the link below to submit your comments:

http://www.ema.europa.eu/pdfs/human/regaffair/submitcomment.doc

We would be grateful if you could disseminate this e-mail to anyone else who might be interested in this document.

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