加拿大处方药与非处方药分类管理制度研究与借鉴

徐敢; 罗卫花; 宋海波

doi:10.6039/j.issn.1001-0408.2023.01.01

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加拿大处方药与非处方药分类管理制度研究与借鉴

药事管理 | 更新时间：2025-09-26

- 加拿大处方药与非处方药分类管理制度研究与借鉴
- Research and reference on the classification management system of prescription drugs and non-prescription drugs in Canada
- 中国药房 2023年34卷第1期页码：1-6
- 作者机构：
  
  1.北京中医药大学管理学院，北京　102488
  2.国家药品监督管理局药品评价中心，北京　100022
- 作者简介：
  
  副主任药师，博士。研究方向：药事管理与药品监管科学。E-mail：xgcg@163.com
  主任药师，博士。研究方向：中药上市后安全性。E-mail：songhaibo@cdr-adr.org.cn
- 基金信息：
  
  国家药品监督管理局中国药品监管科学行动计划第二批重点项目(国药监科外〔2021〕37号)
- DOI：10.6039/j.issn.1001-0408.2023.01.01
  中图分类号： R951
- 收稿日期：2022-07-20，
  
  修回日期：2022-10-31，
  
  纸质出版日期：2023-01-15
- 稿件说明：
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徐敢,罗卫花,宋海波.加拿大处方药与非处方药分类管理制度研究与借鉴[J].中国药房,2023,34(01):1-6.

XU Gan,LUO Weihua,SONG Haibo.Research and reference on the classification management system of prescription drugs and non-prescription drugs in Canada[J].ZHONGGUO YAOFANG,2023,34(01):1-6.
徐敢,罗卫花,宋海波.加拿大处方药与非处方药分类管理制度研究与借鉴[J].中国药房,2023,34(01):1-6. DOI： 10.6039/j.issn.1001-0408.2023.01.01.

XU Gan,LUO Weihua,SONG Haibo.Research and reference on the classification management system of prescription drugs and non-prescription drugs in Canada[J].ZHONGGUO YAOFANG,2023,34(01):1-6. DOI： 10.6039/j.issn.1001-0408.2023.01.01.

摘要

目的

借鉴加拿大处方药与非处方药分类管理制度，为完善我国处方药与非处方药分类管理提供借鉴。

方法

通过分析加拿大处方药与非处方药分类管理制度内容和经验，提出完善我国处方药与非处方药分类管理的思路。

结果与结论

按照处方药与非处方药分类，加拿大将药品分为第Ⅰ类药品、第Ⅱ类药品、第Ⅲ类药品和未分类药品，并对药品分类确立了具体评价因素和管理要求，建有一套比较系统的管理制度、体系和技术标准，这对完善我国处方药与非处方药分类管理制度具有参考和借鉴价值。笔者建议借鉴加拿大处方药和非处方药制度和管理模式，进一步完善我国药品分类管理制度和配套政策，加强处方药和非处方药的精细化分类管理，完善分类注册和转换审查标准。

Abstract

OBJECTIVE

To provide reference for improving the classification management of prescription drugs and nonprescriptiondrugs in China by learning from the classification management system of prescription drugs and non-prescription drugs in Canada.

METHODS

The content and experience of classification management system of prescription drugs and non-prescription drugs in Canada were analyzed， and the thinking of the classification management of prescription drugs and non-prescription drugs in China was proposed.

RESULTS & CONCLUSIONS

According to the classification of prescription drugs and non-prescription drugs， drugs can be divided into class Ⅰ drugs， class Ⅱ drugs， class Ⅲ drugs， unclassified drugs in Canada. Specific evaluation factors and management requirements have been established for drug classification. Canada has established a set of systematic management systems and technical standards， which has reference value for improving the classification management system in China. It is suggested to further improve the drug classification management system and supporting policies， strengthen fine classification management of prescription drugs and non-prescription drugs and improve classification registration and transformation review standards in China， by learning from Canadian prescription drug and non-prescription drug system and management model.

关键词

Keywords

references

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