Towards a robust global framework for conduct and oversight of clinical trials in EU
The European Medicines Agency has published the final reflection paper on ethical and good clinical practice (GCP) aspects of clinical trials of medicinal products for human use conducted outside of the European Union/European Economic Area and submitted in marketing authorization applications to the EU regulatory authorities.
Entering into force on May 1, 2012, the aim of the paper is to strengthen existing processes to provide assurance to regulators and stakeholders that clinical trials meet the required ethical and GCP standards, no matter where in the world they have been conducted.
Addresses increased globalization of R&D
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