Guidance for the publication of clinical data
The European Medicines Agency (EMA) has published detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data.
EMA's pioneering policy entered into force on 1 January 2015 and applies to clinical reports contained in all marketing-authorisation applications submitted on or after this date. The first reports are currently foreseen to be publicly available in September 2016.
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