美国相关政策对我国外向型生物医药的影响及对策建议

The Impact of Relevant United States Policies on Outward-oriented Biomedicine in China and Its Countermeasures and Suggestions

[研究目的]近年来,美国出台的相关政策对我国生物医药外向型发展带来了影响。为推进我国外向型生物医药良性发展,需要对美国相关政策影响进行深入研究,并提出相关建议。[研究方法]定性分析外向型生物医药的发展特点及未来趋势,梳理归纳了美国的相关政策内容,分析了对我国生物医药产业发展、技术研发、市场准入等方面的影响。[研究结论]应当引导企业加强法规与产品合规性认知、增强国内企业硬实力、引导企业优化临床试验策略、积极培养与引进国际化人才、构建完善的海外销售框架等。

[Research purpose]In recent years,the relevant policies introduced by the United States have had an impact on the outward-oriented development of biomedicine in China.In order to promote the positive development of China's outward-oriented biomedicine,it needs to do a deep research about American policies and throw out suggestions.[Research method]This paper qualitatively analyzes the development characteristics and future trends of outward-oriented biomedicine,sorts out and summarizes the relevant policy content of United States,and lists policy suggestions on this basis,analyzing influences on the development of biomedicine industry,technology research and development,market access and so on.[Research conclusion]This paper puts forward countermeasures and suggestions from some aspects,including guiding enterprises to strengthen their awareness of regulations and product compliance,enhancing the hard power of domestic enterprises,guiding enterprises to optimize clinical trial strategies,actively cultivating and introducing international talents,and building a sound international sales framework.