The European Ombudsman, Emily O’Reilly has opened an inquiry into the pre-submission activities organised by the European Medicines Agency (EMA).
The EMA offers several opportunities to developers for early consultation before submitting a marketing authorisation application which it says are "intended to provide regulatory and scientific support to facilitate the preparation of applications and enable a smooth validation and assessment procedure".
However, the Ombudsman has voiced concern about such activities, saying that while they may aid the development and availability of high-quality medicine, they are not without risk. The "eventual decisions by EMA on the authorisation of medicines may be influenced by what has been discussed during the meetings with medicine developers prior to receiving their marketing authorisation application," she said.
In a letter to the EMA's Executive Director, Mr Guido Rasi, the Ombudsman said, "even if EMA were to ensure that its subsequent assessments of applications for marketing authorisations 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." These risks, she said, must be managed.
The Ombudsman has requested a meeting with the EMA and asked that the organisation detail their procedures around such activities.