EMA Policy 0070

The European Medicines Agency Policy 0070 governs the agency’s approach to the prospective publication of clinical data in the agency’s possession. The policy was finalized on October 2, 2014, effective from 1 January 2015 but its implementation is happening in stages, beginning with the publication of Clinical Study Reports (Autumn 2016).  A second phase (Phase 2) is planned for the future, to cover third party access to individual participant data.  The official title of Policy 0070 is “European Medicines Agency policy on publication of clinical data for medicinal products for human use.”

Online here: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf