“港澳药械通”新药遴选评估维度及指标建立

Establishment of Evaluation Dimensions and Indicators for the Selection of New Drugs Based on the"Hong Kong and Macao Medicine and Equipment Connect"Policy

目的建立“港澳药械通”新药遴选评估维度及指标。方法参考香港地区和澳门地区的注册管理体系和注册要求,以及医院新药引进制度,以《香港大学深圳医院新药评估循证医学原则》等为基础,明确遴选评估维度、指标和评价内容。结果以药学特性、有效性、急需性、安全性、伦理审查、社会效益6个维度、15个遴选指标建立了“港澳药械通”新药遴选模式,完善了港澳药品风险防范与管理措施。结论为粤港澳大湾区其他医疗机构开展药品遴选工作提供参考。

Objective To establish evaluation dimensions and indicators for the selection of new drugs based on the″Hong Kong and Macao Medicine and Equipment Connect″policy.Methods With reference to the Hong Kong egion and Macao egion drug registration management systems and requirements and the new drug application system in the hospital,the selection and evaluation dimensions,indicators,and content were clearly defined based on the Principle of Evidence-Based Medicine for New Drug Evaluation in the University of Hong Kong-Shenzhen Hospital.Results A new drug selection model based on the″Hong Kong and Macao Medicine and Equipment Connect″policy was established with fifteen indicators under six dimensions,including pharmaceutical properties,efficacy,urgency,safety,ethics review,and social benefit.The risk prevention and management measures for drugs in Hong Kong and Macao were improved.Conclusion This provides a reference for other medical institutions in the Guangdong-Hong Kong-Macao Greater Bay Area to carry out drug selection.