摘要
Nowadays, CFDA has released a series of reform documents in drug registration review system, which may optimize the new drug evaluation model to accelerate the development of drugs. In this review, we summarized the qualifications and features of expedited approaches in drug review and approval in China, and compared these approaches with FDA. In conclusion, the expedited programs of drug approval in China have been gradually established and translated into policy benefits for drug makers and patients.
近期,CFDA发布了一系列药品注册审评制度改革的文件,希望通过优化新药的审批路径,来促进新药的上市,以满足日益扩大的临床需求。本文总结了中国药品加快审批的路径,并与美国FDA的成功经验进行比较,总结其中存在的特征与问题。目前,中国正在逐步推动建立药品的加快审批路径,希望可以使新药研发和患者共同受益。
