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European Medicines Agency Reveals New Structure



EMA reorganizes to cover drugs' lifecycles



By Gil Roth



Published September 16, 2013
Related Searches: Development
The European Medicines Agency (EMA) has announced details of its new organizational structure. The moves are intended to support better its public and animal health mission and focuses on three key elements:
  • How to better support the scientific work of the of the EMA committees;
  • How to better share the knowledge and information the Agency holds throughout the EU medicines regulatory network;
  • How to better meet the need of the Agency’s stakeholders and partners.

Professor Guido Rasi, EMA's executive director, commented, “My aim is to give our scientific committees the best possible support, alongside the expertise from the national agencies, to help them keep delivering high-quality, consistent opinions. These changes will enable us to use our resources more efficiently and effectively and ensures that the Agency is better prepared for future legislative and policy challenges.”

The changes are the beginning of a transition period as the EMA revises its operating processes, which is expected to be completed in 2014. In order to maintain business as usual, applicants, marketing authorization holders and other stakeholders will continue to work with their current EMA liaison staff and product team leaders unless informed otherwise.

The reorganization introduces a new operating model for how medicines are managed through their entire lifecycle at EMA, with separation of the scientific and procedure management. According to an agency statement, "With the increasing number and complexity of applications being handled by EMA's committees, this is intended to reinforce the robustness and quality of EMA's output and allow development of greater specialities able to respond and support the work of the committees." The new structure has four new divisions with responsibilities throughout the lifecycle of a medicine for human use:
  • Human Medicines Research and Development Support Division,
  • Human Medicines Evaluation Division,
  • Procedure Management and Business Support Division,
  • Inspections and Human Medicines Pharmacovigilance Division.

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.

Also, a new division for stakeholders and communication has been 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. More information about the reorganization and other changes at the EMA can be found at its website, www.ema.europea.eu.


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