The European Ombudsman has publicly expressed her concerns about an apparent “significant change of policy” by the European Medicines Agency (EMA) regarding clinical trial data transparency. In a letter to the EMA on 13 May, 2014, and a subsequent press release on 16 May, the Ombudsman refers to draft documents produced by the EMA that indicate a turn in the Agency’s long-held commitment to the proactive publication of clinical trial data.
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