The European Medicines Agency (EMA) has announced details of its new organisational structure, with four new Divisions at its core.
The new structure reflects a renewed focus on three key elements, it says:
- how to better support EMA committees’ scientific work;
- how to better share the knowledge and information held by the Agency throughout the European Union (EU) medicines regulatory network; and
- how to better meet the needs of EMA stakeholders and partners.
The Agency points out that the changes, announced on September 16, are just the beginning of a transition period as it revises its operating processes, expected to be completed in 2014. And it will ensure continuity of operations, which means applicants, marketing authorisation (MA) holders and other stakeholders should continue working with their current Agency liaison staff and product team leaders, unless informed otherwise, it says.
The new structure has as its core four new Divisions with responsibilities throughout the lifecycle of a human-use medicine, from development to use in patients: - Human Medicines Research and Development Support Division; - Human Medicines Evaluation Division; - Procedural Management and Business Support Division; and – Inspections and Human Medicines Pharmacovigilance Division.
The reorganisation introduces a new operating model for how medicines are managed through their entire lifecycle at the Agency, separating the scientific and procedure management. As the applications being handled by Agency committees grow in number and complexity, this seeks to reinforce the robustness and quality of EMA output and allow development of greater specialties able to respond to and support the committees’ work.
A new Division for Stakeholders and Communication will provide improved coordination of Agency relations with stakeholders, particularly patients and healthcare professionals, support for small and medium-size enterprises (SMEs), and a dedicated communication service.
The new organisational structure is underpinned by functions providing advice to the EMA and its executive director, Prof Guido Rasi, on operational and scientific issues. In addition to the existing Senior Medical Officer, International Affairs, Audit and Legal Department functions, new roles of Chief Policy Adviser and Head of Programme Design Board have been created.
The changes will reshape the EMA so that it is ready to handle future challenges and seize opportunities, says Prof Rasi.
They “will enable us to use our resources more efficiently and effectively and ensure that the Agency is better prepared for future legislative and policy challenges,” he added.