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欧洲药品评价与监测网络:编码、警戒与监测支持

The EUROCET Network: Support for Coding, Vigilance and Surveillance.

作者信息

Mareri Maura, Filippetti Marzia, Ghirardini Angelo, Vespasiano Francesca, Ciaccio Paola Di, Nanni Costa Alessandro

机构信息

Italian National Transplant Centre, Rome, Italy.

出版信息

Transfus Med Hemother. 2011 Dec;38(6):352-356. doi: 10.1159/000334848. Epub 2011 Nov 17.

DOI:10.1159/000334848
PMID:22403518
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3267997/
Abstract

BACKGROUND

In the last years, there have been increasing concerns about the safety and traceability of human tissues and cells in Europe. In order to regulate this part of medical practice, the European Commission issued 3 directives between 2004 and 2006 and endorsed EUROCET to support member states in fulfilling some of their obligations. MATHODS: EUROCET created a connection with the European Union (EU) Competent Authorities (CAs) and set up a website where lists of the CAs, the authorized Tissue Establishments (TEs) and the activity data are published and updated. Moreover, EUROCET is involved within the Vigilance and Surveillance of Substances of Human Origin (SOHO V&S) project, aiming to support the EU member states in the establishment of vigilance and surveillance systems for tissues and cells. EUROCET is also working with EU stakeholders to develop a common coding system concerning donation and products. RESULTS: There are 33 countries in EUROCET and 57 CAs. 3,974 TEs are recorded: 1,108 for tissues, 1,480 for haematopoietic progenitor cells and 1,386 for assisted reproduction. On the website, it is possible to find the 2010 activity data report. CONCLUSION: Based on its cooperation with the CAs, EUROCET represents them in the European network. Nowadays, the EU member states can rely on a web portal and database in order to put the tissue and cell directives into practice.

摘要

背景

近年来,欧洲对人体组织和细胞的安全性及可追溯性的担忧日益增加。为规范这部分医疗实践,欧盟委员会在2004年至2006年间发布了3项指令,并认可欧洲细胞组织库协会(EUROCET)协助成员国履行部分义务。方法:EUROCET与欧盟主管当局建立联系,并设立了一个网站,在该网站上发布并更新主管当局、获授权的组织机构及活动数据的列表。此外,EUROCET参与了人类源物质的警戒与监测(SOHO V&S)项目,旨在支持欧盟成员国建立组织和细胞的警戒与监测系统。EUROCET还与欧盟利益相关者合作,开发有关捐赠和产品的通用编码系统。结果:EUROCET涵盖33个国家和57个主管当局。记录在案的组织机构有3974个:1108个为组织类,1480个为造血祖细胞类,1386个为辅助生殖类。在该网站上可以找到2010年活动数据报告。结论:基于与主管当局的合作,EUROCET在欧洲网络中代表他们。如今,欧盟成员国可以依靠一个门户网站和数据库来实施组织和细胞指令。