EMA Argues Pre-Submission Activities Under Ombudsman's Radar Are A Legal Requirement
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.
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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.
Sept. 30 is the date by which the European Commission must complete its assessment of member states’ bids to host the European Medicines Agency after Brexit. The agency has again highlighted the pressures it is under as a result of the relocation, and the situation has worsened after some LGBT staff members expressed concern about their rights in certain potential host countries in eastern Europe.
Some regulatory activities have been on hold at the European Medicines Agency as it prepares for the impact of the UK’s departure from the EU. The EMA is also concerned that unexpectedly high staff losses will seriously affect its ability to operate.