摘要
目的:为我国药典标准体系的完善提出合理化建议,增强我国药典标准组成的系统性、内容的先进性、匹配的协调性.方法:以中国、美国、欧洲、日本、英国以及国际药典标准体系为研究对象,综合采用文献法、类型比较法、深度访谈法,对《中国药典》《美国药典-国家处方集》《欧洲药典》《日本药局方》《英国药典》《国际药典》的标准体系进行比较和分析.结果:随着科技的飞速发展,以及为加深使用者对监管目标的理解,各国及地区的药典标准体系均在体系架构、新技术标准制定、标准协调等方面不断完善.结论:我国药典标准体系应进一步完善体系架构,明确执行方式,增强与我国药品监管部门发布的指导原则的制定机制和收载内容的一致性和支持性,加强新技术标准的制定和标准的国际协调,加大鼓励企业参与药品标准工作的举措力度.
Abstract
Objective:This study aims to provide rational suggestions for improving the standard system of Chinese Pharmacopoeia,enhancing the systematization of its standard composition,the progressiveness of its content,and the coordination of its alignment with international standards.Methods:This study focuses on the standard systems of pharmacopoeia in Chinese,United States,European,Japanese,British and International Pharmacopoeias.Literature review,type comparison,and in-depth interviews were used to compare and analyze the standard systems of Chinese Pharmacopoeia,the current edition of US Pharmacopoeia/National Formulary,European Pharmacopoeia,Japanese Pharmacopoeia,British Pharmacopoeia,and International Pharmacopoeia.Results:With the rapid development of technology and in order to deepen users'understanding of regulatory objectives,the pharmacopoeia standard systems in different countries(regions)are constantly improving,particularly in system framework,the development of new technology standards,and standard harmonization.Conclusion:The standard system of Chinese Pharmacopoeia should further improve its system framework,clarify its implementation methods,enhance the consistency and support of the development mechanism and content of the guidelines issued by China's drug regulatory bodies,strengthen the formulation of new technology standards,enhance international standard coordination,and increase measures to encourage enterprises to participate in drug standardization efforts.
基金项目
2023年中国药品监督管理研究会课题(2023-Y-Y-003)
维普
万方数据