我国附条件批准上市抗肿瘤药物探讨  

Conditional Approval for Marketing of Antitumor Drugs in China

作　　者：宋茵茵 徐文峰[1] 胡欣[1] 金鹏飞[1] SONG Yinyin;XU Wenfeng;HU Xin;JIN Pengfei(Department of Pharmacy,Beijing Hospital·National Center of Gerontology·Institute of Geriatric Medicine,Chinese Academy of Medical Sciences·Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application,Beijing,China 100730;Department of Pharmacy Administration and Clinical Pharmacy,School of Pharmaceutical Sciences,Peking University,Beijing,China 100191)

机构地区：[1]北京医院药学部·国家老年医学中心·中国医学科学院老年医学研究院·北京市药物临床风险与个体化应用评价重点实验室<北京医院>,北京100730 [2]北京大学药学院药事管理与临床药学系,北京100191

出　　处：《中国药业》2022年第19期12-18,共7页China Pharmaceuticals

基　　金：国家卫生健康委员会药物政策与基本药物制度司2021年度委托研究课题[NHC-YZS-202103]。

摘　　要：目的规范我国抗肿瘤药物附条件批准上市的程序,保障患者用药的可及性。方法梳理国家药品监督管理局药品审评中心截至2022年2月公开的附条件批准上市抗肿瘤药物的上市审评信息,总结我国抗肿瘤药物附条件批准上市品种和所附条件。结果我国附条件批准上市程序取得了一定成效,目前已有15个抗肿瘤药物、涉及19个适应证通过附条件批准上市,其上市所附条件均涉及上市后临床研究计划和上市后风险管理计划,但多数抗肿瘤药物所附条件未明确上市后研究完成日期和最终临床研究报告提交日期。结论我国附条件批准上市程序相应实施细则仍需继续完善。在技术审评方面,仍需要通用、规范的技术指南或共识支持附条件批准上市的技术审评,并引导药品研发企业正确认识附条件批准的制度要求和具体内涵,以保障我国抗肿瘤药物附条件批准上市程序的规范实施,进而保障肿瘤患者的用药可及性。Objective To standardize the procedure of conditional approval for marketing of antitumor drugs in China,and to ensure the accessibility of drug use for patients.MethodsThe review information for marketing of antitumor drugs with the conditional approval for marketing released by the Center for Drug Evaluation,NMPA(CDE)as of February 2022 was sort out,and the varieties and conditions of antitumor drugs with the conditional approval for marketing in China were summaried.Results The procedure of conditional approval for marketing of antitumor drugs in China had certain achievements.At present,15 antitumor drugs involving 19 indications had been approved for marketing with conditions,and the approval conditions all involved the clinical research plan and risk management plan after the antitumor drugs were marketed.However,the approval conditions of most antitumor drugs did not specify the completion date of the research and the submission date of final clinical research report after the antitumor drugs were marketed.Conclusion The corresponding implementation rules of the procedure of conditional approval for marketing of antitumor drugs in China are still need to be improved.In terms of technical review,we still need some general and standardized technical guidelines or consensuses to support the technical review of conditional approval for marketing,and we also need to guide the enterprises of drug research and development to correctly understand the system requirements and specific connotation of conditional approval to ensure the standardized implementation of the procedure of conditional approval for marketing of antitumor drugs in China,and to ensure the accessibility of drug use for patients with tumor.

关 键 词：抗肿瘤药物 附条件批准 上市程序 药品监管 

分 类 号：R95[医药卫生—药学] R979.1