中国食品药品监管Issue(5)：10-25,16.DOI:10.3969/j.issn.1673-5390.2024.05.002
我国先进治疗药品的范围及分类研究和建议
Research and Suggestions on the Scope and Classification of Advanced Therapy Medicinal Product in China
卢加琪 1韦薇 1鲁爽 1王庆利 1何伍 1王涛 1刘丹 1寇雅真 1王雪 1陈昊 1王文波 1尹华静 1王晶 1孙涛1
作者信息
摘要
Abstract
In recent years,the development and registration of advanced therapy medicinal product(ATMP)have shown explosive growth,leading the third industrial revolution of biomedicine.Different types of cell and gene therapy products,such as CAR-T cell therapy products and AAV gene therapy products,have been approved worldwide,offering effective treatments for relapsed and refractory diseases.ATMP are typically genetically modified and/or manufactured via in vitro manipulation of cells or tissues,including genetically modified cells,nucleic acids,viral vectors,and tissue engineering products.Due to the complexity and diversity of ATMP,clarifying their definition and classification is conducive to optimizing the drug registration path,accelerating the release of technical guidelines for various products,promoting the rapid development and marketing of ATMP,and fostering international regulatory convergence.This article investigates the definition and regulatory classification of ATMP in FDA,EMA,and PMDA.It proposes a description and classification of ATMP for drug regulation in China based on the current landscape of ATMP applications and review experiences,which could serve as a reference for formulating relevant policies and regulations.关键词
先进治疗药品/药品监管/法律法规/分类/细胞治疗药品/基因治疗药品Key words
advanced therapy medicinal product/drug regulation/laws and regulations/classification/cell therapy medicinal products/gene therapy medicinal products分类
医药卫生引用本文复制引用
卢加琪,韦薇,鲁爽,王庆利,何伍,王涛,刘丹,寇雅真,王雪,陈昊,王文波,尹华静,王晶,孙涛..我国先进治疗药品的范围及分类研究和建议[J].中国食品药品监管,2024,(5):10-25,16.
