欧洲药品管理局

欧洲药品管理局英語:)是一个欧盟药品评估机构。1995年至2004年这一段时间内,名為歐洲藥物檢驗局英語:[1]

歐洲聯盟政府機構
歐洲藥品管理局
European Medicines Agency
機構概要
成立時間1995年1月1日 (1995-01-01)英國倫敦
机构驻地 荷蘭阿姆斯特丹
格言Science. Medicines. Health.
授權法源Regulation (EC) No. 726/2004
網站www.ema.europa.eu

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

  1. 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.

延伸閱讀

  • McCormick, John. . Boulder, Colo: Westview Press. 2004. ISBN 0-8133-4202-3.

参见

  • 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

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