EMA to draft policy on public access to clinical data

05/5/2013 | PharmaTimes (U.K.)

The European Medicines Agency has announced a timetable for its policy on publicly releasing medical data from clinical trials. The EMA plans to release the draft policy in June, receive public comments through September and publish its final policy at the end of November, with implementation scheduled for January 2014. The final policy will take into account rulings on court cases challenging data transparency mandates, including a recent European Union interim court injunction in favor of drugmakers AbbVie and InterMune. The EMA said its final policy will balance public health interests with the need for patient confidentiality and protection of intellectual property rights.

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