‘Give Us More On Warning On Publishing Our Clinical Data,’ Industry Implores EMA
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.
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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.
As the European Medicines Agency presses on with fine-tuning the guidelines supporting its landmark transparency policy on proactively publishing clinical data, industry says it is not entirely happy with the way that recent revisions have been introduced and will be looking for alternative solutions. Meanwhile, the EMA says there has been “a positive atmosphere of collaboration” with the companies whose data have been published so far and that it is creating a group to tackle the tricky concept of anonymization.