EMA’s Clinical Data Policy One Year On: 50 Products, 3,000 Documents And ‘Positive Feedback’

The European Medicines Agency has published more than 3,000 clinical documents on 50 individual medicines since its policy on the proactive publication of clinical data came into effect in October 2016. It says it has had “positive feedback” from those who have accessed data under the policy.

Clinical trial
The EMA says its clinical data publication policy has proved popular with users.

Clinical study reports on 50 medicines, including orphans, biosimilars, generics and pediatric drugs, have been made publicly available since the European Medicines Agency’s policy on the proactive publication of clinical data was launched a year ago, the EMA has announced.

“This amounts to 3,279 clinical documents, totalling more than 1.3 million pages,” the agency said

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