European Medicines Agency releases details of reorganisation
Aims to its improve efficiency and effectiveness
The European Medicines Agency (EMA) has released the first details of its reorganisation following a review begun last December.
The Agency will replace the current two units that deal with medicines for human use with four divisions focused on: support to the R&D phase; medicines evaluation and lifecycle management; procedure management and business data; and inspections and pharmacovigilance.
The current entities responsible for veterinary medicines, ICT and administration will remain unchanged, except perhaps for their names.
By making these changes, the EMA aims to support the scientific work of the EMA committees better, share the data the Agency holds more effectively, and better meet the needs of its stakeholders and partners.
The new organisational structure is expected to take effect from August. The full structure will be implemented over a period of 18 months.
EMA says it will publish the new organisation structure in the coming months, once the details have been agreed.
Professor Guido Rasi, EMA Executive Director, said: ‘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 EMA’s operations, at a time when all public bodies are being asked to do more with less.
In addition to supporting the committees, the changes recognise that the EMA is increasingly a central data and knowledge hub for the European medicines network as a whole. The data it holds will be increasingly shared with partners and stakeholders.
The changes also 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.