Ombudsman Probes Whether Industry Can Influence EMA In Pre-Submission Meetings
The European Medicines Agency’s practice of holding pre-submission meetings with drug developers is being investigated by the European Ombudsman, who believes there is scope to make such interactions more transparent to tackle concerns over possible bias.
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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.
The new head of the European Medicines Agency will need some solid leadership skills to steer the agency through the challenges of Brexit and to engage on issues including quality of innovation, affordability of medicines and improving patient access.
The European Medicines Agency maintains it is fulfilling a legal obligation by organizing early interaction meetings with drug developers. The regulator is meeting with the EU Ombudsman, who is investigating whether such interactions can influence the agency’s decisions on marketing authorization applications.