摘要
目的 为完善我国药典机构和药品监管机构发布的相近内容指导原则(通用技术要求)的制定机制和收载内容提供参考借鉴.方法 通过梳理中国、美国、欧洲、日本药典机构和药品监管机构发布的内容相近的指导原则(通用技术要求),从制定目的、适用范围和具体内容的相同点、区别点、相互引用情况进行比较和分析.结果 在制剂、生物制品、稳定性、杂质、溶出度、微生物检测、分析方法验证等方面,中、美、欧、日药典机构和药品监管机构存在相近内容的指导原则(通用技术要求),在制定目的和侧重点上有所差异.除我国外,其他国家或地区药典机构和药品监管机构发布的相近内容指导原则(通用技术要求)中重复内容较少,没有相互冲突的内容,两者相互补充,共同支撑药品标准体系 结论 建议由我国药品监管机构牵头确定主题,进一步优化完善协调机制,根据各机构的职能,协调、统一药典机构和药品监管机构制定的指导原则(通用技术要求),确保两者在制定目的、适用范围和收载内容上定位清晰.加强两者的互操作性,并与国际标准保持同步.
Abstract
OBJECTIVE To provide reference and guidance for improving the development mechanism and content of guidelines(general technical requirements)for similar content published by Chinese pharmacopoeia commission and drug regulatory agency.METHODS By reviewing the similar guidelines(general technical requirements)published by pharmacopoeia commissions and drug regu-latory agencies in China,the United States,Europe,and Japan,a comparison and analysis were conducted on their similarities,differences,and mutual references in terms of their development purposes,scope of application,and specific content.RESULTS In terms of prepara-tions,biological products,stability,impurities,dissolution,rmicrobiological testing methods,and validation of analytical methods,pharmaco-poeia commissions and drug regulatory agencies in China,the United States,Europe,and Japan have similar guidelines(general technical requirements),and there are differences in the purposes and focuses.Except for China,other countries or regions have less repetitive content and no conflicting content in the guidelines(general technical requirements)for similar content published by pharmacopoeia commissions and drug regulatory agencies.The two complement each other and jointly support the drug standard system.CONCLUSION It is recommended that China's drug regulatory agency take the lead in determining the subjects,further optimizing and improving the harmonization mechanism,and harmonizing and unifying the guidelines(general technical requirements)developed by pharmacopoeia commission and drug regulatory agency based on the functions of each agency,to ensure that the two are clearly positioned in terms of development purposes,scopeof application,and content.Strengthen the interoperability of similar content guidelines published by pharmacopoeia agency and drug regulatory agency and keep pace with international standards.
基金项目
中国药品监督管理研究会研究课题(2023-Y-Y-003)
维普
万方数据