新时代我国药品上市后监测评价工作思考

Post-marketing Surveillance and Evaluation of Chinese Drugs in the New Era

立足我国药品监管新使命、新理念、新制度、新形势,对我国药品上市后监测评价工作面临的机遇和挑战进行分析,并结合国内现状与国际发展,提出了加快完善监测评价制度体系、持续提升监测评价体系能力、着力防控药品安全风险、研究上市后监测评价新方法、努力打造高效能信息化系统等方面的思考。

Based on new missions,new ideas,new regulatory systems,and new situation regarding drug supervision,this article analyzes the opportunities and challenges facing post-marketing surveillance and evaluation of drugs in China.In view of the status quo in China and development worldwide,recommendations are offered as to how to improve the regulatory system quickly,continue to enhance the capabilities of monitoring and evaluation,work hard to prevent drug safety risks,research new post-marketing surveillance and evaluation methods,and establish highly efficient information systems.