20160120 ECA新闻：药物警戒：GVP更新和EMA新闻

20160120 ECA新闻：药物警戒：GVP更新和EMA新闻

GMP News
20/01/2016

Pharmacovigilance: GVP Updates and EMA Newsletter

药物警戒：GVP更新和EMA新闻

The European Medicines Agency (EMA) has published drafts of the following revised and new modules and documents of the Guideline on good pharmacovigilance practices (GVP):

EMA已公布了以下优良药物警戒规范指南（GVP）中修订过的和新的模块和文件：

• GVP module XV (Safety Communication) with the corresponding templates. The proposed changes focus on:
• GVP模块XV（安全沟通）及对应的模板。所提出的变化主要在：
• 1) The introduction of the concept of core EU direct healthcare professional communications (DHPCs) for the situation where a common DHPC prepared at EU level may not be suitable because of differences in the DHPCs required at the level of Member States (e.g. differences in available alternative treatments) and the PRAC/CHMP therefore agree(s) on core messages only;
• 介绍核心EU DHPCS概念，如果一个普通的DHPC准备EU水平可能不适用，因为不同成员国对DHPC要求不同（例如，可以获得的替代性治疗有差异），因此PRAC/CHMP仅同意核心信息；
• 2) The introduction of the option that one marketing authorisation holder may act on behalf of other marketing authorisation holders with a goal of disseminating one single DHPC in situations where several marketing authorisation holders are concerned;
• 介绍如果涉及多个上市许可持有人的话，一个上市许可持有人可以代表另一个上市许可持有人采取行动，来发布一个单个的DHPC
• 3) Adjustments of references to other GVP modules, given the recently revised GVP structure;
• 其它GVP模块的索引调整，如果最近有修订过GVP结构的话
• 4) Editorial improvements throughout the Module.
• 模块中编辑性改进
• GVP product- or population-specific considerations II: biological medicinal products. This draft of a new GVP chapter covers aspects regarding pharmacovigilance specifically for this product group.
• GVP产品，或人群，特别考量II：生物药品。该草案新GVP章节包括了产于药物警戒问题，特别是这类产品。
  

Comments on those drafts should be sent to EMA until 29 February 2016. You can find the drafts on the Eudralex Volume 9 GVP website under "Draft GVP chapters and annexes for public consultation".
对这些草案的建议应在2016年2月29日之前发送至EMA。你可以在EUDRALWX 第9卷GVP网页上找到这些草案。
The chapters on product- or population-specific considerations have now been developed for vaccines and biological medicinal products. Two more consideration chapters are planned: P III Pregnancy and breast-feeding and P IV Geriatric population. These chapters are expected to be released for public consultation in the second quarter of 2016.
关于药品或人群特定考量的章节现在已经起草了疫苗和生物药品方面的内容。还有2个考量章节正在计划中：PIII孕妇和哺乳期妇女和PIV老年人群。这些章节预期会在2016年第2季度公布征求意见。
The EMA further released an Addendum I "Educational materials" with regard to GVP module XVI "Risk minimisation measures - Selection of tools and effectiveness indicators". The document has been in force since 16 December 2015. It describes the requirements on the creation, submission, distribution and supply of educational materials. For the safe use of some medicinal products additional information might be required. This supplementary information has to be provided in form of "educational material" in addition to SmPC (Summary of Product Characteristics) and package leaflet.
EMA还发布了一份关于GVP模块XVI“风险降低措施---工具选择和有效性指标”的“备忘I学习材料”。该文件已自2015年12月16日起实施。它描述了关于创建、提交、分发和供应学习材料的要求。为了一些药品的安全使用，可能会需要额外的信息。在SMPC（产品特性总结）和包装说明书之外，这些补充信息已采用“学习材料”的方式提供。
EMA Newsletter "Pharmacovigilance programme update - Issue 6 available:
In July 2014, the EMA has also started a Newsletter focussing on pharmacovigilance ("News bulletin for pharmacovigilance programme update"). With this quaterly issued  Newsletter, EMA keeps informed all marketing authorisation holders (MAHs) of the latest developments in the field of pharmacovigilance. Now, the sixth Newsletter is available. Among other things, it contains news and timetables on the following topics:

EMA新闻信“药物警戒程序更新”第6期现在可以获取。

2014年7月，EMA还开始发布聚集于药物警戒的新闻信（药物警戒项目更新新闻板）。采用该份每季发布的新闻函，EMA向所有上市许可持有人发布最新的警戒信息。现在，第6期已经可以获取。除了其它内容外，它包括了以下专题新闻和时间表：

• Medical Literature Monitoring
• 药品文献监测
• Database of Medicinal Products Article 57
• 第57条规定的药品数据库
• PSUR Repository
• PSUR存贮
• Pharmacovigilance Fees
• 药物警戒费用
• Adverse drug reaction reporting and Signal management
• 药物不良反应报告和信号管理
  

Qualified Persons for Pharmacovigilance (QPPVs) who are registered in the XEVMPD database according to Article 57 of Regulation (EG) No 726/2004 receive this document directly via EudraLink. You can find the Newsletter on the website of the EMA.

根据第57条在XEVMPD数据库中登记的药物警戒的授权人（QPPV）将直接从EUDRALINK链接收到该文件。你可以在上述网址中找到。

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