EU Watchdog Says EMA Experts Shouldn’t Advise On and Evaluate the Same Meds

July 25, 2019

EMA experts who give scientific advice to a drug developer pre-application should not be involved in evaluating the medicine, the EU’s internal watchdog advised last week.

The EU Ombudsman — whose role is to investigate complaints about EU agencies — opened an inquiry in July 2017 into the pre-submission scientific advice the EMA gives to developers. It concluded that the agency runs the risk of losing its neutrality when it provides advice and evaluations for the same drugs.

“To the greatest extent possible, EMA should ensure that there is a separation between those responsible for providing scientific advice to a medicine developer and those subsequently involved in evaluating a marketing authorization application (MAA) for the same medicine,” the ombudsman said.

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