「欧洲药物管理局」(European Medicines Agency) (EMA或EMEA) 的前身是「欧洲药物检验局(European Agency for the evaluation of Medicinal Products)」,其地位相当于美国的食品暨药物管理局(Food and drugAdministration)。EMA在欧盟、制药工业和会员国的赞助下,于1995年成立,目的是在协调会员国间国家级的药物检验单位,以节省新 药在引进欧洲的过程中,会员国间重复审查的费用,并消弥在新药引进过程中,个别国家中的保护政策。EMA的诞生是欧盟政府花了七年的时间,为取代 原设立于'1977年专利药物委员会(Committee for ProprietaryMedicinal Products) 和畜用药物委员会(Committee for VeterinaryMedicinal Products)。由于新技术的引进与发展和行政上的一些修正,「欧洲药物检验局」于2004年改名为「欧洲药物管理局」,总管人畜用药的授权、顾问和 药物安全监视。2009年EMA内部再次改组,以因应日益复杂的业务。目前,EMA有超过3500名的专家,500多名的员工。
The predecessor of the "European Medicines Agency" (EMA or EMEA) is the "European Agency for the evaluation of medical products", which is equivalent to the food and Drug Administration of the United States. EMA was established in 1995 under the sponsorship of the European Union, the pharmaceutical industry and Member States. Its purpose is to coordinate national drug testing units among Member States, so as to save the cost of repeated review among member states in the process of introducing new drugs into Europe, and eliminate the protection policies of individual countries in the process of introducing new drugs. The birth of EMA took the EU government seven years to replace the Committee for proprietary medical products and the Committee for veterinary medical products established in '1977. Due to the introduction and development of new technologies and some administrative amendments, the "European drug inspection agency" was renamed the "European Drug Administration" in 2004 to manage the authorization, consultation and drug safety monitoring of human and animal drugs. In 2009, EMA was reorganized again to cope with the increasingly complex business. At present, EMA has more than 3500 experts and more than 500 employees.