Page 7 - 《中国药房》2020年23期

·药事管理·

欧盟传统草药注册制度对我国经典名方简化注册监管体系的启

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葛文霞 ，钱欣诚，邵 蓉（中国药科大学国家药物政策与医药产业经济研究中心，南京 211198）
中图分类号 R951 文献标志码 A 文章编号 1001-0408（2020）23-2817-05
DOI 10.6039/j.issn.1001-0408.2020.23.01

摘 要 目的：为完善我国经典名方简化注册制度监管体系的建设提供参考。方法：从监管机构、监管法规体系、简化注册条件、
简化注册目录、注册资料要求等方面对欧盟传统草药和我国经典名方简化注册制度进行比较研究，并在欧盟传统草药简化注册制
度的经验基础上，提出对完善我国经典名方简化注册制度的建议。结果与结论：欧盟设有专门的草药药品委员会进行注册监管工
作；建立了从指令到具体指南的完善的监管法规体系；注重传统草药的人用历史和使用条件；发布了欧盟草药专论和欧盟草药目
录，并以此作为安全有效性依据，对注册资料进行进一步减免。我国由国家药品监督管理局与国家中医药管理局共同负责经典名
方注册监管工作，目前已经发布了简化注册审批的相关文件，但缺少相应的实施细则和指南。我国同样重视经典名方的临床使用
经验，并强调制备方法、剂型等与古代典籍的一致性。目前，我国已经发布了包括100个经典名方在内的《古代经典名方目录（第
一批）》，目录内的经典名方注册申报时可免除部分注册资料。我国可以借鉴欧盟经验，结合经典名方监管的实际情况建立专家委
员会，以质量控制和风险管控为重心完善简化注册监管体系，优化经典名方遴选条件，探索制定经典名方专论，从而进一步激发我
国中药产业创新活力。
关键词 欧盟；传统草药；注册制度；经典名方；简化注册；启示

Enlightenment of the European Union’s Traditional Herbal Medicine Registration System to the Simplified
Registration and Monitoring System of Chinese Classical Formulas
GE Wenxia，QIAN Xincheng，SHAO Rong（Research Center of National Drug Policy and Ecosystem，China
Pharmaceutical University，Nanjing 211198，China）

ABSTRACT OBJECTIVE：To provide reference for improving the monitoring system of simplified registration system of Chinese
classical formulas. METHODS：A comparative study was conducted on the simplified registration system of traditional herbal
medicines in the European Union and Chinese classical formulas from the aspects of regulatory agencies，regulatory systems，
simplified registration conditions，simplified registration catalogs and registration data. On the basis of the experience of the
simplified registration system of traditional herbal medicines in the European Union，some suggestions were put forward to improve
the simplified registration system of Chinese classical formulas. RESULTS & CONCLUSIONS：The European Union establishes
special committee on traditional herbal medicine for registration and supervision；has established a complete regulatory system from
directives to specific guidelines；focuses on the history and conditions of the use of traditional herbal medicine；has published the
European Union monographs and European Union list，which are used as a basis for safety and effectiveness to further reduce or
exempt registration data. In China，National Medical Products Administration and the National Administration of Traditional
Chinese Medicine are jointly responsible for the registration and supervision of classical formulas. At present，the relevant
documents to simplify the registration and approval have been issued，but there is no corresponding implementation rules and
guidelines. China also attaches great importance to the clinical experience of classical formulas，and emphasizes the consistency of
preparation methods and dosage forms with ancient classics. Recently，China has published the Catalogue of Ancient Classic
Formula（the First Batch），including 100 classical formulas，and the classic formulas in the catalogue can be exempted from
relevant registration materials when applying for registration. Our country can learn from the experience of the European Union and
combine the actual situation of classic formulas supervision to establish an expert committee，focus on quality control and risk
control to improve registration and supervision system，optimize the selection conditions of classic formulas，and explore the
classic formulas monographs， to further stimulate the
Δ 基金项目：国家社会科学基金重大项目（No.15ZDB167）
innovation vitality of traditional Chinese medicine industry.
＊硕士研究生。研究方向：医药政策与法规。电话：025-86185193。
KEYWORDS European Union； Traditional herbal
E-mail：jsrdgwx@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 medicine； Registration system； Chinese classical formulas；
规。电话：025-86185193。E-mail：shaorong118@163.com Simplified registration；Enlightenment

中国药房 2020年第31卷第23期 China Pharmacy 2020 Vol. 31 No. 23 ·2817 ·