中国药品综合评价体系亟待建立和完善

对药品进行综合评价,尤其是对药品上市后的再评价是风险控制的重要手段,也是提升治疗作用、扩大治疗用途的必然方法.本文综述了药品评价的意义、内容和方法.介绍了国外发达国家在药品评价机构和制度建设方面的先进经验,以及我国药品评价相应的法规和技术指导原则以及药品评价研究情况.指出我国亟需建立适合中国特色,同时具有可操作性的药品综合评价体系.

Establishment of Comprehensive Drug Evaluation System in China Needs to Be Completed and Further Improvement

A comprehensive drug evaluation system, especially post-marketing drug evaluation, is the guarantee of drug safety management and risk control. Herein the importance of drug evaluation and methods to evaluate it were reviewed. Advanced experiences in other countries were introduced, and drug evaluation regulations and guidelines in our country were summarized. Therefore, the comprehensive drug evaluation system in China should fit in the domestic situation and be operative.