Research and Suggestions on the Scope and Classification of Advanced Therapy Medicinal Product in China
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.
国家科技期刊平台
NSTL
万方数据
