组织工程与重建外科杂志

组织工程与重建外科杂志 ›› 2014, Vol. 10 ›› Issue (5): 244-246.doi: 10.3969/j.issn.1673-0364.2014.05.002

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基因治疗产品、细胞治疗产品和组织工程产品在欧盟的监管

韩倩倩，王春仁   

  1. 中国食品药品检定研究院
  • 发布日期:2020-07-23

Regulation of Products of Gene Therapy, Cell Therapy and Tissue Engineering in European Union

HAN Qianqian,WANG Chunren   

  1. National Institutes for Food and Drug Control;
  • Published:2020-07-23
  • Contact: 国家自然科学支撑计划（2012bai22b01）；863课题（2012aa020507）；中科院先导计划课题（xda01030504，xda01030503）

摘要： 欧盟将基因治疗产品、细胞治疗产品和组织工程产品定义为先进医疗产品(Advanced therapy medicinal products,ATMP),以专门的规定对此类产品进行管理,包括此类产品的技术要求、获准上市的程序、临床试验要求和生产要求。目前,我国对于此类产品还没有明确的监管法规。本文将介绍欧盟在此类产品上的监管法规,为我国探索和实践此类产品的监管提供参考。

关键词: 先进医疗产品, 欧盟, 监管法规

Abstract: Products of gene therapy, cell therapy and tissue engineering are defined as advanced therapy medicinal products （ATMP） by European Union. There are special rules to manage these products, including technical requirements, approval proposal, requirements for clinical trials and production. There were still no definite administrative regulations for these products in China. In this paper, the administrative regulations in European Union were introduced to provide some reference for our country.

Key words: Advanced therapy medicinal products, European Union, Administrative regulation

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