Comparative Study on Pharmacopoeia Standard Systems in Chinese,United States,European,Japanese,British and International Pharmacopoeias
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.
万方数据
维普
