EMA publishes Reflection Paper on ethical and GCP Aspects of Clinical Trials conducted in third Countries

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:

  • Clarify the practical application of ethical standards for clinical trials, in the context of European Medicines Agency activities.
  • Determine the practical steps undertaken during the provision of guidance and advice in the drug development phase.
  • Determine the practical steps to be undertaken during the Marketing Authorisation phase 169
  • International cooperation in the regulation of clinical trials, their review and inspection and capacity building in this area.

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:

  • Clarification of the practical application of ethical standards for clinical trials on medicinal products for human use in the context of the European Medicines Agency activities
  • Determine the practical steps to be undertaken during the provision of guidance and advice in the drug development phase
  • Determine the practical steps to be undertaken during the marketing authorisation phase
  • International cooperation in the regulation of clinical trials, their review and inspection and capacity building in this area
  • Regulatory action overview

Comments on this reflection paper should be sent to ctrefpaper@ema.europa.eu by 30 September 2010.

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