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我国《临床急需境外新药名单》纳入品种及优化策略研究
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蒋 丰 ，田 侃 （1.南京中医药大学卫生经济管理学院，南京 210023；2.南京中医药大学养老服务与管理
1＊
学院，南京 210023）

中图分类号 R95 文献标志码 A 文章编号 1001-0408（2023）01-0007-05
DOI 10.6039/j.issn.1001-0408.2023.01.02

摘 要 目的 对我国《临床急需境外新药名单》的纳入品种及优化策略进行研究，以更好地满足患者用药需求。方法 对我国《临
床急需境外新药名单》的发布过程、临床急需境外新药的品种特点与属性、《临床急需境外新药名单》落实过程中存在的问题等进
行分析，并就如何优化完善《临床急需境外新药名单》提出对策建议。结果与结论 《临床急需境外新药名单》的发布过程大致可分
为孕育阶段、准备阶段和实施阶段。3批临床急需境外新药的治疗领域相对集中于内分泌和代谢病、肿瘤、皮肤疾病，纳入的73个
品种中已经有50个品种获批上市，26个品种被纳入医保，4个品种被纳入《鼓励仿制药品目录》。当前我国临床急需境外新药还存
在短缺监测制度有待建立健全、与医保的联动减弱、鼓励仿制力度不足等问题。应当加强临床急需境外新药短缺监测的部门协同
联动，建立以临床价值为导向的医保支付体系，完善鼓励仿制临床急需境外新药的配套激励机制。
关键词 临床急需境外新药名单；品种；优化策略

Study on the varieties included in the List of Overseas New Drugs Urgently Needed in Clinic in China and
the optimization strategy
JIANG Feng ，TIAN Kan（1. School of Health Economics and Management， Nanjing University of Chinese
2
1
Medicine， Nanjing 210023， China；2. School of Elderly Care Service and Management， Nanjing University of
Chinese Medicine， Nanjing 210023， China）

ABSTRACT OBJECTIVE To study the variety included in the List of Overseas New Drugs Urgently Needed in Clinic in China
and optimization strategy， in order to better meet the needs of patients. METHODS The release process of List of Overseas New
Drugs Urgently Needed in Clinic， the characteristics and attributes of the new drugs urgently needed abroad， and the problems in
the implementation process were all analyzed to put forward some suggestions for optimizing the List of Overseas New Drugs
Urgently Needed in Clinic. RESULTS & CONCLUSIONS The release process of the List of Overseas New Drugs Urgently Needed
in Clinic was roughly divided into incubation stage， preparation stage and implementation stage. The treatment fields of 3 batches
of overseas new drugs urgently needed in clinic were relatively concentrated on endocrine and metabolic diseases，tumor and skin
diseases. Of included 73 varieties， 50 varieties have been approved for market，and 26 varieties have been included in the medical
insurance， 4 varieties were included in the Catalogue of Encouraged Generic Drugs. At present， there are still some problems in
our country， such as the shortage monitoring system needs to be established and improved； the linkage with medical insurance is
weakened； the encouragement of generic drugs is insufficient. It is necessary to strengthen the cooperation of monitored departments
in the shortage of new overseas drugs，establish a medical insurance payment system oriented by clinical value， and improve the
incentive mechanism to encourage the imitation of overseas new drugs urgently needed in clinic.
KEYWORDS List of Overseas New Drugs Urgently Needed in Clinic； variety； optimization strategy

临床急需境外新药指的是近十年在美国、欧盟或日 优势的药品。《临床急需境外新药名单》是我国为了加快
本上市但未在我国境内上市的新药，包括用于治疗罕见 临床急需境外新药在境内上市而发布的药品名单，被纳
病的药品、防治严重危及生命且尚无有效治疗或预防手 入《临床急需境外新药名单》的品种可按照《临床急需境
段的药品和防治严重危及生命的疾病且具有明显临床 外新药审评审批工作程序》提交相关资料，直接提出上

Δ 基金项目 江 苏 省 中 医 药 管 理 局 科 技 发 展 委 托 专 项（No. 市申请，国家药品监督管理局药品审评中心（Center For
2021WTZX02） Drug Evaluation，CDE）会建立专门的通道加快审评，进
＊第一作者 硕士研究生。研究方向：药事管理。电话：025- 而更好地满足我国患者的用药需求 。自 2018 年 11 月
[1]
85811760。E-mail：1574027967@qq.com
CDE 发布《第一批临床急需境外新药名单》起，到 2022
# 通信作者 教授，博士生导师，硕士。研究方向：药事管理。电
话：025-85811760。E-mail：tiankan@njucm.edu.cn 年 5 月已发布了 3 批《临床急需境外新药名单》，累计纳

中国药房 2023年第34卷第1期 China Pharmacy 2023 Vol. 34 No. 1 · 7 ·