EMA asked to explain pre-submission meetings amid 'perception of bias' risk

European Ombudsman Emily O’ Reilly has written to Guido Rasi, executive director of the European Medicines Agency (EMA), to notify him of her inquiry into the regulator’s meetings with drug companies before they have submitted marketing authorization applications (MAAs).

While recognizing that these activities, which allow drug developers to establish contact with agency staff who will be involved with the application, might help with swift drug development, Ms O’ Reilly writes that they might pose some risks of influencing eventual EMA decisions on MAAs.

“Even if the EMA were to ensure that its subsequent assessments of applications for marketing authorizations are objective and complete, there is still a risk that pre-submission activities create, in the eyes of the public, at least some perception of bias,” the letter adds. “These risks must be managed.”