Operations
The European Medicines Agency operates as a decentralized scientific agency (as opposed to a regulatory authority) of the European Union and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. More specifically, it coordinates the evaluation and monitoring of centrally authorized products and national referrals, developing technical guidance and providing scientific advice to sponsors. Its scope of operations is medicinal products for human and veterinary use including biologics and advanced therapies, and herbal medicinal products. The agency is composed of the Secretariat (ca. 600 staff), a management board, six scientific committees (human, veterinary and herbal medicinal products, orphan drugs, pediatrics and advanced therapies) and a number of scientific working parties. The Secretariat is organized into five units: Directorate, Human Medicines Development and Evaluation, Patient Health Protection, Veterinary Medicines and Product Data Management, Information and Communications Technology and Administration. The Management Board provides administrative oversight to the Agency: including approval of budgets and plans, and selection of Executive Director. The Board includes one representative of each of the 27 Member States, two representatives of the European Commission, two representatives of the European Parliament, two representatives of patients’ organisations, one representative of doctors’ organisations and one representative of veterinarians’ organisations. The Agency decentralizes its scientific assessment of medicines by working through a network of about 4500 experts throughout the EU. The EMA draws on resources of over 40 National Competent Authorities (NCAs) of EU Member states.
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“It may seem strange that any road through such a wilderness should be passable, even in winter, when the snow is three or four feet deep, but at that season, wherever lumbering operations are actively carried on, teams are continually passing on the single track, and it becomes as smooth almost as a railway.”
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“There is a patent office at the seat of government of the universe, whose managers are as much interested in the dispersion of seeds as anybody at Washington can be, and their operations are infinitely more extensive and regular.”
—Henry David Thoreau (1817–1862)