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[交流] 欧洲药品评价局从2012年3月开始发布处于评估期的新药申请信息 已有1人参与

为了增加透明性,欧洲药品评价局从2012年3月开始发布处于评估期的新药申请信息,并且每月更新。
附件为第一次发布的文件。
European Medicines Agency publishes list of human medicines under evaluation
The European Medicines Agency has published a list of all new human medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP).

The list includes the international non-proprietary names (INNs) and therapeutic areas for all new innovative medicines under evaluation, along with information on the type of salt, ester or derivative of the active substance. For generic and biosimilar medicines, it includes the INN and therapeutic area. The list only includes medicines whose applications have been validated.

The Agency will update this information every month following the plenary meeting of the CHMP.

This initiative forms part of the drive towards increased transparency on its activities by the Agency and other European regulatory authorities. It follows the publication of recommendations on transparency of ongoing evaluations adopted by the European Medicines Agency and the Heads of Medicines Agencies in November 2010.

INNs or generic names are the globally recognised names used to identify active ingredients in pharmaceuticals. INNs are selected by the World Health Organization (WHO).
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  • 附件 1 : WC500123528.pdf
  • 2012-03-12 10:07:38, 140.05 K

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2楼2012-03-12 10:15:10
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