The European pharmacovigilance: regulatory aspects

被引：0

作者：

Dhanani, A ^{[1
]}

Castot, A ^{[1
]}

机构：

[1] AFSSAPS, Dept Vigilances, Direct Evaluat Medicaments & Prod Biol, F-93285 St Denis, France

来源：

PRESSE MEDICALE | 2000年 / 29卷 / 02期

关键词：

D O I：

暂无

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Establishment: The European pharmacovigilance system has been operating since 1995 when the European Agency for the Evaluation of Medicinal Products as well as two new European registration procedures were established. Structure: This system is very similar to the French organization and is based on a decentralized collection and validation of safety data by member states and a centralized evaluation and decision making process at the European Agency for the Evaluation of Medicinal Products performed by the Committee for Proprietary Medicinal Products (CPMP) and its Pharmacovigilance Working Party. A European system: In light of the experience gained, the European pharmacovigilance system moved to an interactive system which relies on a close cooperation between member states ensuring the common evaluation and management of safety concerns.

引用

页码：107 / 110

页数：4

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