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精神疾病药物监管政策:欧洲是否达标?

Regulatory policies on medicines for psychiatric disorders: is Europe on target?

作者信息

Barbui Corrado, Garattini Silvio

出版信息

Br J Psychiatry. 2007 Feb;190:91-3. doi: 10.1192/bjp.bp.106.024794.

Abstract

The European Medicines Agency (EMEA) is the regulatory body that provides the institutions of the European Community with the best possible scientific advice on the quality, safety and efficacy of medicinal products. Drugs approved by the EMEA are automatically marketable in all the European member states. Since the beginning of the EMEA's activities a number of drugs acting on the central nervous system obtained marketing authorisation. This editorial highlights some aspects of the EMEA rules that may negatively affect the evaluation of medicines for psychiatric disorders.

摘要

欧洲药品管理局(EMEA)是一个监管机构,它就药品的质量、安全性和有效性向欧洲共同体各机构提供尽可能完善的科学建议。经EMEA批准的药物可在所有欧洲成员国自动上市销售。自EMEA开展活动以来,许多作用于中枢神经系统的药物获得了上市许可。本社论着重强调了EMEA规则中可能对精神疾病药物评估产生负面影响的一些方面。

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