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The European Medicines Agency (EMA) has announced details of its new organizational structure. The changes fundamentally reorganize the Agency’s operations to support better its public and animal health mission, and its role as part of the European medicines regulatory system. The new structure reflects a renewed focus on three key elements:
The changes announced today are the beginning of a transition period as the Agency revises its operating processes, expected to be completed in 2014. While work continues to further refine the organizational structure, the Agency will ensure continuity of operations. This means that applicants, marketing authorization holders and other stakeholders should continue to work with their current EMA liaison staff and product team leaders unless informed otherwise.
The new structure has at its core four new Divisions with responsibilities right through the lifecycle of a medicine for human use from development to use in patients. Those are:
Veterinary medicines are managed through a single Division that has been re-focused to deal solely with veterinary medicines and animal health. Information technology and administration continue to be managed through separate Divisions.
A new Division for Stakeholders and Communication is created to provide improved coordination of the Agency’s relations with stakeholders, in particular patients and healthcare professionals, support for small and medium-sized enterprises, and a dedicated communication service.
The new organizational structure is underpinned by advisory functions, which provide advice to the Executive Director and the Agency on operational and scientific issues in their fields of expertise. In addition to the existing functions of Senior Medical Officer, International Affairs, Audit and the Legal Department, this also includes the newly created roles of Chief Policy Adviser and Head of Program Design Board.