The European Medicines Agency (EMA) has updated its [size=1em]procedural guidance on[size=1em]periodic safety update reports (PSURs) to simplify the way marketing authorisationholders present proposed changes to the product information of nationally authorised medicines in PSURs subject to a single assessment.
EMA更新了关于PSURs的程序指南以简化PSURs中国家批准的药物的信息的变更来方便评估。
EMA will start to pilot this simplified approach in January 2015.
2015年01月份试行。
The simplification relates to the requirement detailed in the Good PharmacovigilancePractices (GVP) Module VII. Until now, proposed changes to the product informationrequired submission of tracked-changes versions of all national product informationcovered by a particular PSUR. With the revision, companies can now choose to use a simplified approach as detailed in the procedural guidance.
GVP的VII部门详细介绍了关于这个要求的简化。现在，产品信息的变更还是在PSUR中递交。修订后，公司可以使用更简单的方法。 http://www.ema.europa.eu/ema/ind ... =WC0b01ac058004d5c1
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发表于 2015-1-10 09:42:19
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