欧洲前沿疗法药物的监管、审批及其启示

Supervision and approval of advanced therapy medicinal products in European and its inspirations

对前沿疗法药物( advanced therapy medicinal products,ATMPs) 的发展以及欧洲近年来 ATMP的监管科学、监管框架和审批进行了详细的文献回顾和深入分析。EMA 对 ATMP 的分类与定义较为科学,监管框架和法律法规不断完善,对 ATMP 进行严格的评估和上市许可准入;同时又充分考虑到 ATMP 的自身特点,在审批路径上兼具一定的灵活性,并对 ATMP 给予积极的产业引导与扶持,值得我们学习和借鉴。

A detailed review and in-depth analysis of the development,regulatory science,regulatory framework and approval of advanced therapy medicinal products(ATMPs)in Europe were provided in this article.The classification and definition of ATMPs in Europe are relatively mature.The regulatory framework as well as laws and regulations are continuously improved.The ATMPs are strictly evaluated and licensed for market access.At the same time,EMA adopt flexible approval methods for ATMPs by taking full account of the characteristics of ATMPs.EU also takes positive industrial guidance to support them.All these practices are worthy of our study and reference.