European Medicines Agency Reorganizes - - BioPharm International

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European Medicines Agency Reorganizes


The European Medicines Agency (EMA) has released details about its restructuring. The reorganization, first announced in December 2012 and expected to be completed in 2014, focuses on supporting scientific work of the various EMA committees, sharing information throughout the European Union’s regulatory system, and meeting the needs of stakeholders and partners.

The new structure introduces an operating model for managing drugs through their entire lifecycle, with separation of the scientific and procedure management. EMA will increase the number and complexity of applications being handled by the Agency’s committees to reinforce the robustness and quality of the Agency’s output. The reorganization creates four new divisions: Human Medicines Research and Development Support, Human Medicines Evaluation, Procedure Management and Business Support, and Inspections and Human Medicines Pharmacovigilance. A new Division for Stakeholders and Communication will provide improved coordination of the Agency’s relations with patients and healthcare professionals, support for small and medium-sized enterprises, and a dedicated communication service.

“The changes announced today will reshape the EMA so that it is ready to handle future challenges and seize opportunities,” said Professor Guido Rasi, EMA Executive Director in a press release. “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.”

Source: European Medicines Agency

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