Page 7 - 《中国药房》2025年12期

·药事管理·

我国非处方药市场准入优化路径现状调研及国际经验应用建议
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卢 娜 ，郝海平 ，丁佐奇 （1.中国药科大学国际医药商学院，南京 210009；2.中国药科大学药学院，南京
210009；3.中国药科大学《中国天然药物》编辑部，南京 210009）
中图分类号 R95 文献标志码 A 文章编号 1001-0408（2025）12-1417-07
DOI 10.6039/j.issn.1001-0408.2025.12.01

摘 要 目的 为优化我国非处方药（OTC）市场准入流程提供参考。方法 在文献调研的基础上设计调查问卷，通过问卷星平台
向来自医药企业、药品监管机构、行业协会、医疗机构和高校的受访者发放问卷，对回收的调查数据进行统计分析。结果 共回收
154份问卷，均为有效问卷。58.5%的受访者来自医药企业，18.8%的受访者来自药品监管领域，另有22.7%的受访者来自高校和
医疗机构；超过半数受访者的工作年限≥10年。89.6%的受访者呼吁建立OTC独立审评体系；88.3%的受访者认为有必要建立符
合我国国情的OTC专论制度；73.4%的受访者认为应规范专论纳入程序及流程；77.3%的受访者认为应完善处方药转换为OTC的
具体流程；91.0%的受访者认为真实世界数据/证据可有助于简化OTC上市路径，但在数据质量和数据获取方面存在难点。结论
我国OTC市场准入机制审评周期较长，建议我国可参考国际经验，构建“制度重构-技术革新-监管创新”三位一体的本土化适配优
化路径，为建立科学高效的OTC监管体系提供决策依据。
关键词 非处方药；市场准入；注册审评；路径优化；国际经验

Current situation research on the optimization path of market access for over-the-counter drugs in China
and suggestions for the application of international experience
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LU Na ，HAO Haiping ，DING Zuoqi 1， 3 （1. School of International Pharmaceutical Business， China
Pharmaceutical University， Nanjing 210009， China；2. School of Pharmacy， China Pharmaceutical University，
Nanjing 210009， China；3. Editor Office of Chinese Journal of Natural Medicines， China Pharmaceutical
University， Nanjing 210009， China）

ABSTRACT OBJECTIVE To provide a reference for optimizing the market access process for over-the-counter drugs （OTC） in
China. METHODS Based on literature review， questionnaire survey was designed and distributed via the Wenjuanxing platform to
respondents from pharmaceutical enterprises， drug regulatory agencies， industry associations， medical institutions and universities.
The collected survey data were then subjected to statistical analysis. RESULTS A total of 154 questionnaires were collected， all of
which were valid. Among the respondents， 58.5% were from pharmaceutical enterprises， 18.8% were from the field of drug
regulation， and the remaining 22.7% were from universities and medical institutions. More than half of the respondents had been
working for 10 years or more. A total of 89.6% of the respondents called for the establishment of an independent review system for
OTC. Additionally， 88.3% believed it was necessary to establish an OTC monograph system based on China’s national conditions.
Meanwhile， 73.4% of respondents believed it was necessary to standardize the monograph inclusion procedures and processes，
while 77.3% thought the specific process for switching prescription drugs to OTC status should be improved. Furthermore， 91.0%
of the respondents considered that real-world data/evidence could contribute to simplifying the OTC market approval pathway，
although challenges related to data quality and data accessibility were acknowledged. CONCLUSIONS The review cycle for
China’s OTC market access mechanism is relatively long. A localized adaptation and optimization path of “institutional
reconstruction-technological innovation-regulatory innovation” in a trinity is proposed to provide a decision-making basis for
establishing a scientific and efficient OTC regulatory system with international experience serving as a reference.
KEYWORDS OTC； market access； registration review； path optimization； international experience

我国自2000年实施药品分类管理制度以来，已初步
Δ 基金项目 江苏省药品监督管理局药品监管科学科研计划项目
构建了处方药与非处方药（over-the-counter drugs，OTC）
（No.202451） 的差异化监管框架，并明确了两类药品在流通、使用及
＊第一作者 硕士研究生。研究方向：管理药学（监管科学）。E-
监管中的界限。2020 年新修订的《药品注册管理办法》
mail：ln15555389156@163.com
# 通信作者 教授，博士生导师，博士。研究方向：科学计量学和科 进一步规范了 OTC 的注册审评流程，确立了以“处方药
技评价研究。E-mail：zqding1028@163.com 转换”和“直接注册”为主的双轨制准入模式。然而，我

中国药房 2025年第36卷第12期 China Pharmacy 2025 Vol. 36 No. 12 · 1417 ·