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EMA Heeds Ombudsman’s Advice On Avoiding Perception Of Bias In Drug Evaluations

Changes Are In Response To An Inquiry By EU Ombudsman

 
• By Vibha Sharma

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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EMA Is Making Changes To Avoid Even The Perception Of Bias • Source: Shutterstock

The European Medicines Agency is to introduce certain procedural changes to ensure there is “to the greatest extent possible” separation between the experts it uses to offer companies scientific advice about a drug and the experts who are subsequently involved in reviewing the same medicine.

The changes, which are likely to be introduced in the first quarter of 2020, are in response to an inquiry...

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