Page 7 - 《中国药房》2022年16期

·药事管理·

获益与风险视角下的地标中药饮片跨省流通监管问题分析 Δ

丁瑞琳 ，蒋 蓉，邵 蓉（中国药科大学药品监管科学研究院/国家药品监督管理局药品监管创新与评价重点
#
＊
实验室，南京 211198）

中图分类号 R95；R288 文献标志码 A 文章编号 1001-0408（2022）16-1921-06
DOI 10.6039/j.issn.1001-0408.2022.16.01

摘 要 目的 为解决我国执行地方标准的中药饮片（以下简称“地标中药饮片”）跨省流通的争议问题提供思路。方法 通过模拟
场景和收集实际案例，列举我国地标中药饮片跨省流通的几种情形，检索官方网站或访谈药品监管相关人员，梳理我国地标中药
饮片跨省流通监管现状，并基于利益相关者理论探讨相关主体的获益与风险，从获益、风险平衡的视角提出相关政策建议。结果
与结论 我国地标中药饮片跨省流通大致可分为3种情形：外省企业按照本省地标生产饮片并流通至本省销售使用、外省企业按照
生产企业所在省地标生产饮片并流通至本省销售使用、外省企业按照第三省地标生产饮片并流通至本省销售使用。目前国家尚
无法律性文件明确统一对地标中药饮片跨省流通问题的监管要求，地方监管意见主要来源于药品监管部门官网对在线咨询的回
复，仅山东、上海、辽宁、江西发布了复函或规范性文件。分别有41.9％、38.7％、32.3％的省份允许上述3种情形的地标中药饮片
跨省流通；另还有32.3％、16.1％、22.6％的省份对上述3种情形的监管态度尚不明确。相关利益主体的获益和风险分析显示，有
条件地允许地标中药饮片跨省流通更符合获益、风险平衡的科学监管理念，但监管效果取决于监管策略的科学性。建议药品监督
管理部门厘清中药饮片国家标准和地方标准的关系，差异化收载品种；出台较高层级的法律文件，明确地标中药饮片跨省销售的
监管要求；丰富监管措施和手段，逐步调整地标中药饮片的跨省流通要求。
关键词 药品监管；地方标准；炮制规范；中药饮片；跨省流通；利益相关者

Analysis of trans-provincial distribution supervision of TCM decoction pieces in accordance with provincial
standards from the perspective of benefit and risk
DING Ruilin，JIANG Rong，SHAO Rong（Institute of Drug Regulatory Science/NMPA Key Laboratory for Drug
Regulatory Innovation and Evaluation，China Pharmaceutical University，Nanjing 211198，China）

ABSTRACT OBJECTIVE To provide ideas for solving the dispute of trans-provincial distribution of traditional Chinese
medicine （TCM） decoction pieces in accordance with provincial standards （hereinafter referred to as“local TCM decoction
pieces”）. METHODS Through simulation scenarios and collecting actual cases，the conditions of trans-provincial distribution of
local TCM decoction pieces were listed；the official websites were searched or relevant personnel of drug supervision were
interviewed；the current situation of trans-provincial distribution supervision of local TCM decoction pieces in China were sorted
out. Based on the stakeholder theory，the benefits and risks of main stakeholders were discussed to put forward relevant suggestions
from the perspective of benefit/risk balance. RESULTS & CONCLUSIONS The conditions of trans-provincial distribution of local
TCM decoction pieces in China included enterprises in B province produced TCM decoction pieces according to the A provincial
standards，sold and used them in A province；enterprises in B province produced TCM decoction pieces according to the B
provincial standards，sold and used them in A province；enterprises in B province produced TCM decoction pieces according to the
C provincial standards，sold and used them in A province. At present，there are no clear relevant provisions of national laws about
trans-provincial distribution supervision of local TCM decoction pieces. Local regulatory opinions mainly come from the reply of
the official website of drug regulatory department to online consultation，and only Shandong，Shanghai，Liaoning and Jiangxi have
issued replies or normative documents. Totally 41.9％，38.7％ and 32.3％ of the provinces respectively allow the trans-provincial
distrbution of local TCM decoction pieces in the above 3 conditions；in addition，32.3％ ，16.1％ and 22.6％ provinces have
unclear regulatory attitudes towards the 3 conditions. The benefits and risks analysis of relevant stakeholders shows that it is more in
line with the scientific regulatory concept of benefit/risk balance to conditionally allow trans-provincial distribution of local TCM
decoction pieces，but the regulatory effect depends on the scientificity of the regulatory strategy. It is suggested that the drug
regulatory departments clarify the relationship between the
Δ 基金项目 国家社会科学基金重大项目（No.15ZDB167）
national and local standards for TCM decoction pieces and
＊第一作者 博士研究生。研究方向：医药政策与法规。E-mail：
differentiate the varieties of collection；clear the regulatory
dingrl375@163.com
# 通信作者 教授，博士生导师，博士。研究方向：医药政策与法 requirements for trans-provincial distribution of local TCM
规。电话：025-86185188。E-mail：shaorong118@163.com decoction pieces by issuing high-level legal documents；enrich

中国药房 2022年第33卷第16期 China Pharmacy 2022 Vol. 33 No. 16 ·1921 ·