对研发药物的安全有效性和质量可控性做出科学合理的评价,以更好地为促进国民健康用药服务,是我国药品评价者需要不断深入思考的课题。而借鉴国外药品评价历程中的实践经验为我所用,是提高评价水平的有效方式。现对美国和我国药品技术评价体系中的异同点进行比较,旨在促进我国药品评价体系的完善,不断提高评价水平;同时也引导药品研发者有的放矢,提高研发效率。 To scientifically and reasonably evaluate the safety and effectiveness of research and development of drugs and quality controllability so as to better serve the promotion of national health drug use is a topic that our drug evaluators need to continuously think in depth. It is an effective way for me to improve the evaluation level by referring to the practical experience in the evaluation process of foreign drugs for my own use. The similarities and differences between the United States and China in the drug technology evaluation system are compared to promote the improvement of the drug evaluation system in our country and constantly improve the evaluation level. Meanwhile, the drug developers are also targeted to improve the R & D efficiency.