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

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.