The European Medicines Agency (EMA) has published for public consultation a 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.
In Dec 2008 the EMA published a strategy paper "Acceptance of clinical trials conducted in third countries for evaluation in Marketing Authorisation Applications" outlining four areas for action. These are:
In 2009 the EMA established a Working Group on third country clinical trials on medicinal products for human use. This working Group has been asked to develop practical proposals for tasks and procedures or guidance to address the four action areas set out above. The reflection paper reflects the results of the discussion of this Working Group.
The Reflection Paper highlights and emphasizes the need for cooperation between Regulatory Authorities involved in the supervision of clinical trials and the need to extend and link networks to support these activities. The specific scope of this Reflection Paper extends to clinical trials conducted in third countries and submitted in marketing authorisation applications to the EMA in respect of medicinal products for human use:
Comments on this reflection paper should be sent to email@example.com by 30 September 2010.