By eCliniqua Staff
May 3, 2013 | The first details of the planned reorganization of the European Medicines Agency (EMA) were announced this morning. The changes reflect a renewed focus on three key elements: how to better support the scientific work of the EMA committees, how to better share the data the Agency holds and how to better meet the needs of its stakeholders and partners.
At the highest level, the two units currently dealing with medicines for human use will be replaced with four Divisions focused on support to the R&D phase; medicines evaluation and lifecycle management; procedure management and business data; and lastly inspections and pharmacovigilance.
The final organizational structure will be published in the coming months, and will take effect beginning in August. EMA expects the full structure to be implemented over 18 months to ensure continuity of operations.
The changes are the result of a review initiative announced in December 2012. Professor Guido Rasi, EMA Executive Director, said in a statement: “The 2012 annual report highlighted the increased complexity and diversity of the Agency’s activities. My aim is to re-shape the EMA to be ready to handle future challenges and give our scientific committees the appropriate support, alongside the expertise from the national agencies, to help them keep delivering high-quality, consistent opinions. These changes are expected to improve the efficiency and effectiveness of our operations, at a time when all public bodies are being asked to do more with less. It offers a more effective use of existing resources and ensures the Agency is better prepared for future legislative and policy challenges.”
The changes recognize that the EMA is increasingly a central data and knowledge hub for the European medicines network as a whole. Data held by the Agency will be increasingly shared with partners and stakeholders. The Agency’s databases support the evaluation and supervision of medicines by national agencies and the EMA, and by pharmaceutical companies for their own products. The databases also populates the Web portals that serve as the source for public information on medicines in Europe.
The changes aim to improve the way the Agency engages with and supports its stakeholders and partners. This includes more coherent support to pharmaceutical companies during the research and development of new medicines, a new contact function for industry, including small and medium-sized enterprises (SMEs), and consolidation of interactions with patients and healthcare professionals.