[1]牛雨涵,谈在祥.我国应急处方药品跨境进口的现状、问题与对策[J].卫生经济研究,2025,42(10):44-47,51.
 NIU Yuhan,TAN Zaixiang.Current Status, Challenges, and Countermeasures for Cross-Border Importation of Emergency Prescription Drugs in China[J].Journal Press of Health Economics Research,2025,42(10):44-47,51.
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我国应急处方药品跨境进口的现状、问题与对策

卫生经济研究[ISSN:1004-7778/CN:33-1056/F]

卷:
42
期数:
2025年10期
页码:
44-47,51
栏目:
药械管理
出版日期:
2025-09-30

文章信息/Info

Title:
Current Status, Challenges, and Countermeasures for Cross-Border Importation of Emergency Prescription Drugs in China
作者:
牛雨涵1谈在祥234
1.徐州医科大学公共卫生学院,江苏 徐州 221004
2.徐州医科大学管理学院,江苏 徐州 221004
3.徐州医科大学卫生政策与健康管理研究中心,江苏 徐州 221004
4.徐州医科大学附属医院,江苏 徐州 221006
Author(s):
NIU Yuhan TAN Zaixiang
School of Public Health, Xuzhou Medical University, Xuzhou Jiangsu 221004, China
关键词:
应急处方药品跨境进口可及性
Keywords:
emergency prescription drugs cross-border importation accessibility
分类号:
R95
文献标志码:
A
摘要:
随着医疗国际化的推进,患者对境外应急处方药品的需求日益增长。当前,我国应急处方药品进口面临审批流程繁复、未经注册药品使用限制较多、个人跨境购买药品监管困难以及同情用药制度实践障碍等问题。对此,应通过优化审批流程、实施分类管理策略、加强医疗机构药品管理、规范个人跨境购买药品行为、完善同情用药制度等路径,提高应急处方药品的可及性,从而保障患者权益。
Abstract:
With the advancement of medical internationalization, patients' demand for emergency overseas prescription drugs is increasing. Currently, China faces challenges in importing emergency prescription drugs, including cumbersome approval processes, numerous restrictions on unregistered drugs, difficulties in regulating personal cross-border drug purchases, and practical obstacles in implementing compassionate use programs. To address these issues, it is necessary to optimize the approval process, implement classified management strategies, strengthen drug management in medical institutions, regulate individuals' cross-border drug purchasing behavior, and improve the compassionate drug use system, so as to enhance the accessibility of emergency prescription drugs to protect patients' rights and interests.

参考文献/References:

[1] 黄哲,曲若暄,兰毅鹏,等.罕见病药品进口流程与监管建议研究[J/OL].沈阳药科大学学报:1-7.[2023-11-09].
[2] 谢菡,姚瑶,游一中,等.英国未注册药品的管理政策与制度及其对我国的启示[J].药物流行病学杂志,2020,29(11):782-787.
[3] 刘昭,向贵圆,张帆,等.利用跨境电商进口未注册罕见病药品的路径设计与政策建议[J].中国新药杂志,2023,32(05):441-447.
[4] Borysowski J,Górski A.Compassionate use of unauthorized drugs:legal regulations and ethical challenges[J].European Journal of Internal Medicine,2019,65:12-16.
[5] 李丽静,黎运达,包淑娟,等.区块链+特许药械追溯管理的实践与思考[J].中国医药导刊,2020,22(09):654-658.
[6] 常丽梅,李耀华,侯媛媛,等.博鳌乐城国际医疗旅游先行区特许药械政策实施研究与分析[J].中国药事,2022,36(10):1103-1109.
[7] 王芳,刘云鹏,许倍铭,等.某院临床急需进口药品申请问题分析与建议——乐城先行区急需进口药品助力真实世界研究[J]. 中国食品药品监管,2023(10):54-60.
[8] 王广遇,黎琼.可及性视角下专利药品平行进口法律规制研究[J].西部学刊,2021(01):58-61.
[9] Liu Y,Zhang N,Xie C,et al.Evolution of drug regulations and regulatory innovation for anticancer drugs in China[J].Acta Pharmaceutica Sinica B,2022,12(12):4365-4377.
[10] COT?魪 T R,Xu K,Pariser A R.Accelerating orphan drug development[J].Nature Reviews Drug Discovery,2010, 9(12):901-902.
[11] 范瑞雪,袁孝青,杜玉馨,等.我国电子处方流转现状及对策[J].中国药业,2022,31(17):1-6.
[12] 冯晓鹏.从“北京模式”到“河南模式”——跨境电商医药零售进口模式分析[J].中国海关,2022(02):94-96.
[13] 黄梦琴,谈在祥.跨境电商零售进口药品的问题与对策研究[J].卫生经济研究,2022,39(07):49-52.
[14] 陈颖.我国同情用药制度的法律困境及其对策[J].医学与社会, 2022,35(04):139-144.

更新日期/Last Update: 2025-09-30