欧盟发布《个案病例安全报告实施指南》

2015-07-22 MedSci MedSci原创

ISO ICSR(Individual Case Safety Report,个案病例安全报告)是一项用于提高药品疑似不良反应报告的新国际标准,该标准将于2016年7月1日生效。欧洲药品管理局(EMA)为支持这项新国际标准在欧盟(EU)的实施,近期发布了《个案病例安全报告实施指南》。ISO ICSR旨在为全球各地患者发生的涉及某种药物疑似不良反应的病例提供相同的报告格式。该标准实施后,预计有关药品

ISO ICSR(Individual Case Safety Report,个案病例安全报告)是一项用于提高药品疑似不良反应报告的新国际标准,该标准将于2016年7月1日生效。欧洲药品管理局(EMA)为支持这项新国际标准在欧盟(EU)的实施,近期发布了《个案病例安全报告实施指南》。

ISO ICSR旨在为全球各地患者发生的涉及某种药物疑似不良反应的病例提供相同的报告格式。该标准实施后,预计有关药品不良反应和治疗使用的信息将更加全面。另外,该标准还加强了对制药公司和监管机构所收集ICSR记录中个人资料的保护。

该标准将改善收集数据的质量,提高数据检索和分析能力。监管机构将能够更迅速地发现和应对药品安全问题,从而更好地保护患者。

由EMA和药品监管机构负责人组织(HMA)联合制定的《个案病例安全报告实施指南》对于欧盟各成员国的制药公司和药品监管机构具有重要意义,它将有助于他们使用该标准。该指南特别规定了ICSR的电子传输流程、ICSR的格式和内容、报告验证的商业规则以及分类和数据质量的原则。在药物警戒数据库的开发过程中,它还将为软件供应商和IT开发商提供帮助。

该指南的发布是EMA准备建立增强型EudraVigilance系统的重要一步,该系统是一个收集了欧洲经济区(EEA)范围内已上市药品所有疑似不良反应的欧洲数据库,它是按照欧盟药物警戒法规的要求建立的。

附:美国FDA个案病例安全报告》

Individual Case Safety Reports

Description:  The HL7 Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use of FDA regulated products. 

ICSR Release 2 was completed December 2011 as an SDO Joint Initiative Project between the International Standards Organization (ISO), the European Committee for Standardization (CEN) and HL7.  Information about the SDO Joint Initiative can be found at: http://www.jointinitiativecouncil.org/. The ICSR specification, ISO/HL7 27953 is a multi-part standard created to consolidate work efforts in ISO and HL7 as follows:

1. ISO new work item proposal N545: Health informatics - Pharmacovigilance - Structure and data elements of individual case safety report (reclassified as ISO 27953);

2. Health Level Seven (HL7) Individual Case Safety Report (ICSR) Release 1, Normative Standard;

3. HL7 ICSR Release 2, Draft Standard for Trial Use (DSTU)ISO/HL7 27953-1 (Part 1) is designed to address areas of overlap across the work items and form a messaging framework reference. This framework can be applied to support data exchange requirements described in the many different use cases presented as storyboards in this International Standard. This framework allows for future development work to be carried out so that additional use cases that are not currently addressed in this edition can be added in the future as new parts to this International Standard.

ISO/HL7 27953-2 (Part 2) is designed at a conformance profile for Part 1 for use by the International Conference on Harmonisation (ICH) revised guideline E2B(R3): Data Elements for Transmission of Individual Case Safety Reports. The ICH requirements have been further extended to take into account additional international requirements. Use of ISO 27953-2 is dependent upon the related ISO vocabulary harmonization work Identification of Medicinal Products (IDMP), which is a suite of related standards used to uniquely identify regulated products through the product lifecycle (premarket to postmarket). 
Individual Case Safety Report Resources: FDA implementation of the Individual Case Safety Report (ICSR) Standard varies by product type. Implementers should contact the receiving program (e.g., FAERS, VAERS, eMDR, CVM) prior to submission of ICSRs to the Agency. Links to applicable ICSR guidance documents are provided as a resource to clarify ICSR content and format requirements for electronic ICSR submissions to FDA.



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  1. 2015-08-06 hlycom3356

    很不错的哦

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  2. 2015-08-06 hlycom3356

    这指南很有价值

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