EMA Heeds Ombudsman’s Advice On Avoiding Perception Of Bias In Drug Evaluations
Changes Are In Response To An Inquiry By EU Ombudsman
An inquiry by the EU Ombudsman has prompted the European Medicines Agency to introduce changes to ensure that its experts, who advise companies in the premarket phase, are not appointed to evaluate marketing applications for the same drugs.
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The European Medicines Agency has taken possession of its new HQ in Amsterdam and has hired 77 new staff members to make up for the severe staff losses it has witnessed on account of Brexit.
The European Ombudsman has recommended how the European Medicines Agency can avoid even the perception that the decisions it takes on marketing authorization applications are influenced by the pre-submission interactions it has with drug developers.
Five new drugs have been recommended for EU approval at the latest meeting of European Medicines Agency’s drug evaluation committee.