EMA Strengthens Oversight on Clinical Trials

Pharmaceutical Technology, 05/10/2012

The European Medicines Agency (EMA) has published the final reflection paper concerning ethical and good clinical practice (GCP) aspects of clinical trials. The paper applies to trials conducted outside of the EU and the European Economic Area that are submitted in marketing authorization applications to European regulatory authorities, with the aim of ensuring that all trials, no matter where they’re conducted, meet the required standards.

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