欧洲药品管理局
外观
欧洲联盟政府机构 | |
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欧洲药品管理局 European Medicines Agency | |
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机构概要 | |
成立时间 | 1995年1月1日英国伦敦) | (
机构驻地 | ![]() |
格言 | Science. Medicines. Health. |
授权法源 | Regulation (EC) No. 726/2004 |
网站 | www |
欧洲药品管理局(英语:European Medicines Agency, EMA)是一个欧盟药品评估机构。1995年至2004年这一段时间内,名为欧洲药物检验局(英语:European Agency for the Evaluation of Medicinal Products)[1]。
欧洲药品管理局在欧洲的地位大致相当于美国食品药品监督管理局在美国的地位。
参考
[编辑]- ^ Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009.
延伸阅读
[编辑]- McCormick, John. The European Union: Politics and Policies. Boulder, Colo: Westview Press. 2004. ISBN 0-8133-4202-3.
参见
[编辑]- 道德委员会
- EudraCT
- EudraGMP
- EudraLex
- EUDRANET
- EudraPharm
- EudraVigilance
- European and Developing Countries Clinical Trials Partnership
- European Clinical Research Infrastructures Network
- European Federation of Pharmaceutical Industries and Associations
- European Forum for Good Clinical Practice (EFGCP)
- ICH
- Inverse benefit law
- Medicines and Healthcare Products Regulatory Agency (MHRA, UK)
- Qualified Person
- Regulation of therapeutic goods
- Supplementary protection certificate (SPC)
外部链接
[编辑]- 官方网站
- 药品临床应用委员会 (CHMP)
- 兽医药品临床应用委员会 (CVMP)
- Heads of Medicines Agencies (页面存档备份,存于互联网档案馆)
- Agencies of the European Union (页面存档备份,存于互联网档案馆)
- The Rules Governing Medicinal Products in the European Union (页面存档备份,存于互联网档案馆) (EudraLex)
- European Economic Area (页面存档备份,存于互联网档案馆) (EEA)
- Health-EU Portal (页面存档备份,存于互联网档案馆) official public health portal of the European Union
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