摘要
本研究通过文献回顾的方法,系统梳理美国与欧盟在药品监管科学领域运用战略管理思维的具体实践,从愿景目标、战略规划和执行过程等方面,对比分析与我国的异同.我国监管科学框架体系已经逐渐形成和完善,但与欧美等国家相比,在政策引领研发、资源配置、队伍建设、国际交流等方面依然存在不足.本研究运用战略思维,基于我国监管实际,提出通过法律法规顶层设计、优化监管资源配置、审评队伍建设、利益相关方沟通交流以及加强国际交流与合作等途径,全方位提升我国药品监管效能.
Abstract
Through the method of literature review,this study systematically combs through the specific practices of the United States and the European Union in applying strategic management thinking in the field of pharmaceutical regulatory science,and compares and analyses the similarities and differences with our country in terms of vision and goals,strategic planning and implementation process.China's regulatory science framework system has been gradually formed and perfected,but compared with Europe and the United States and other countries,there are still deficiencies in policy-led research and development,resource allocation,team building,and international exchanges.Using strategic thinking and based on China's regulatory reality,it is proposed to enhance the effectiveness of China's drug regulation in all aspects through the top-level design of laws and regulations,optimizing the allocation of regulatory resources,reviewing the team construction,communication among stakeholders,and strengthening international exchanges and cooperation.
维普
万方数据