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.
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Drug companies are worried that the European Medicines Agency is not giving them enough advance notice on when it will contact them to submit their redacted clinical reports under Europe’s landmark transparency policy on proactively publishing clinical data. The EMA, meanwhile, says it is considering a possible solution, that it is taking care to nurture companies that are going through the submission process, and that it is not too bothered about industry missing deadlines.