| 徐昕怡.对中国药典国际协调的探讨和思考[J].中国药事,2019,33(12):1356-1364 |
| 对中国药典国际协调的探讨和思考 |
| Discussion and Reflection on the International Harmonization of Chinese Pharmacopoeia |
| 投稿时间：2019-10-25 |
| DOI：10.16153/j.1002-7777.2019.12.004 |
| 中文关键词: 药典 协调 标准 国际人用药品注册技术协调会 药典讨论组 |
| 英文关键词: pharmacopoeia harmonization standard ICH PDG |
| 基金项目: |
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| 中文摘要: |
| 目的：探析《中华人民共和国药典》国际协调的思路和方法。方法：通过查阅各国药典、国际人用药品注册技术协调会指导原则、药典讨论组协调案、我国相关部门和世界贸易组织发布的标准协调法规文件，并与《中华人民共和国药典》相关内容进行对比，总结各国药典国际协调现状和未来策略，分析《中华人民共和国药典》国际协调的现实意义和应考虑的问题。结果：《中华人民共和国药典》的国际协调应坚持国家整体利益第一的原则，遵循"三腿凳子"理论；采用和参与制定国际协调的药典标准缺一不可，是否采用国际协调的药典标准应结合我国国情决定，不采用国际协调的药典标准应有正当理由；《中华人民共和国药典》应在国际协调基础上坚持特色并转化为国际标准。结论：建议《中华人民共和国药典》建立健全国际协调的制度规范，充分行使制定国际药品标准的权利，从而提高我国药品标准水平，扩大《中华人民共和国药典》的国际影响。 |
| 英文摘要: |
| Objective: Exploring the ideas and methods of international harmonization of the Chinese Pharmacopoeia. Mehtods: By reviewing the Chinese Pharmacopoeia, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines, the Pharmacopoeia Discussion Group harmonization cases, the standard harmonization regulations issued by the Chinese government department and the World Trade Organization, compared with the relevant contents of Chinese Pharmacopoeia, summarized the current status and future strategies of international harmonization of pharmacopoeia, and analyzed the practical significance of the international harmonization of the Chinese Pharmacopoeia and the issues that should be considered. Results: The international harmonization of the Chinese Pharmacopoeia should adhere to the principle of the country's overall interests first, and follow the theory of ‘three leg stools’; the adoption and participation in the development of internationally harmonized pharmacopoeia standards are indispensable, whether to adopt internationally harmonized pharmacopoeia standards or not should be determined in light of China's national conditions, and there should be justification for not adopting internationally harmonized Pharmacopoeia standards; the Chinese Pharmacopoeia should adhere to the characteristics on the basis of international coordination. Conclusion: It is recommended that the Chinese Pharmacopoeia establish the regulations, fully exercise the right to develop international drug standards, so as to improve the level of China's drug standards, and expanding the Chinese Pharmacopoeia international influence. |
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