Industry Wants Fixes To EMA’s Guidance on Clinical Data Publication
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.
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Most of the proposals by companies to redact commercially confidential information in their clinical study reports under the European Medicines Agency’s policy on proactive publication of clinical trial data have been rejected. Meanwhile, the agency is planning to make improvements to the policy this year.
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.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add seven new products, including Nulibry, BridgeBio/Sentynl's orphan drug for treating molybdenum cofactor deficiency Type A.