摘要
目的:通过分析浙江省124家医药企业的问卷调查,探讨“大市场-专药品”监管模式对省域医药产业发展的影响。方法:采用描述性统计和卡方检验法分析相关企业在政策影响和数字化改革上的评价结果及差异性。结果:相关政策或措施对鼓励企业创新具有重要意义;医药企业对行政审批方面的满意度最高,对“长三角地区合作”平台的需求度最高;医药企业对监管部门数字化监管平台的认可度较其自身信息化平台高;医药企业对数字化改革过程中内部数据的安全性有所顾虑。结论:药品监管体制改革应进一步完善针对医药产业发展的政策设计,规范推进产业框架体系,加快推进长三角地区医药产业技术交流平台建设,加强信息共享和技术互助。提升数字监管的覆盖率和智能化程度,增强企业数字化转型的意愿和能力,提升监管部门对数据保护的设施和手段,增加现有平台间的业务协同度。
Objective:To explores the influence of the"big market-special drugs"regulatory model on the development of pharmaceutical industry based on a questionnaire survey of 124 pharmaceutical enterprises in Zhejiang province.Methods:Descriptive statistics and chi-square tests are used to analyze the evaluation results and differences among various types of companies regarding government policies and digital reforms.Results:Government policies and measures are of great significance to encourage enterprise innovation.Pharmaceutical companies are most satisfied with government administrative approvals and exhibit the highest demand for the Yangtze River Delta Cooperation platform provided by the government.Enterprises also show higher recognition of the government's digital supervision platform compared to their own information platforms.Additionally,enterprises will take into account the security of internal data in the process of digital reform.Conclusion:The reform of the drug regulatory system should further focus on the policy design for the development of the pharmaceutical industry,standardize and promote the industrial framework system,accelerate the construction of a technology exchange platform for the pharmaceutical industry in the Yangtze River Delta region,and strengthen information sharing and technical collaboration.Improving the coverage and intelligence of digital regulation,enhancing the willingness and ability of enterprises for digital transformation,improving data protection facilities and measures by regulatory authorities,increasing business synergy between existing platforms,and preventing grassroots formalism and over-digitization in regulation are essential considerations.
作者
沈霞芬
戴维娜
蔡强
吴利芳
姚珏
SHEN Xia-fen;DAI Wei-na;CAI Qiang;WU Li-fang;YAO Yu(Yangtze Delta Region Institute of Tsinghua University,Zhejiang)
出处
《中国食品药品监管》
2023年第7期114-121,共8页
China Food & Drug Administration Magazine
关键词
大市场-专药品
药品监管体制改革
医药产业发展
big market-special drugs
drug regulatory system reform
pharmaceutical industry development
