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欧洲创建药品副作用报告数据库

来源:环球医学编译    时间:2012年06月05日    点击数:    5星

6月5日消息 - 环球医学据悉,欧洲已经推出了一种使公众了解药品可疑副作用的数据库。

总部设在伦敦的欧洲药品管理局(EMA)说,网址为http://www.adrreports.eu/的网上图书馆,到目前为止已包含了约650种药物的有关信息。

EMA说:“今日的数据库的创建......强调了副作用报告以及药物警戒性在维护欧盟内公众健康上的重要性。”

这些报告直接来源于欧盟药品安全数据库——EudraVigilance。

信息来源于患者、医生和制药公司向国家监管当局提交的不良反应报告,制药公司这样做是法定要求,以获得在EU出售药物的许可。

EMA强调,这些数据与可疑副作用有关。

“可疑副作用可能与药物无关或不是由药物引起的,因此,所公布的信息不能被用来判断出现了副作用的可能性,或作为药物有害的象征。”EMA警告说。

这些报告正首先以英文公布,但将会在未来几周内用欧盟的其他22种官方语言推出。(环球医学)

原文:

A Website to Record Side-effects of Medicines

Europe has introduced a database to make the public aware of suspected side effects in medicines. 

The online library, on http:www.adrreports.eu/, so far contains information relating to around 650 drugs, the London-based European Medicines Agency (EMA) said. 

"Today's launch... highlights the importance of side-effects reporting and pharmacovigilance in safeguarding public health within the European Union," it said. 

The reports come directly from the European Union's medicines safety database, called EudraVigilance. 

The information comes from reports of adverse reactions submitted by patients and doctors to national regulatory authorities, as well as by pharmaceutical companies, which are legally required to do this to gain a licence to sell a drug in the EU. 

EMA stressed that the data relate to suspected side effects. 

"Suspected side effects may not be related to or caused by the medicine, and as a result, the published information cannot be used to determine the likelihood of experiencing a side effect or as an indication that a medicine is harmful," it cautioned. 

The reports are being published first in English but should be rolled out in the EU's 22 other official languages in the coming weeks.
 

相关链接:http://www.medindia.net/news/a-website-to-record-side-effects-of-medicines-102086-1.htm 

 

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