Draft policy 70: Publication and access to clinical-trial data

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Document details

Download document Draft policy 70: Publication and access to clinical-trial data
Reference number EMA/240810/2013
Status draft: consultation closed
First published 24/06/2013
Last updated 24/06/2013

Summary

There is growing demand from external stakeholders for full transparency, not only about the European Medicines Agency's deliberations and actions, but also about the data and results from clinical trials on which regulatory decisions are based. Following consultations with a broad range of external stakeholders and European bodies, the Agency has drafted this policy, which complements the existing policy on access to documents (related to medicinal products for human and veterinary use), which came into effect in December 2010.