新中国的药品安全管理体制经历了计划经济、行业管理、市场监管和社会治理四个发展阶段,即从建国初期低水平“药品福利”到新时期“药品民生”的转变,对保障药品安全,促进医药产业发展具有重要意义。为了从根本上保证人民用药的安全问题,必须从顶层设计,重构社会监督、市场调节与政府监管的结构和功能,权衡商业利益与公共利益之间的关系,并建立长效机制。归根到底,要将享受数量充足、质量可控安全的药品作为一种社会权利赋予全体民众,实现药品安全保障体系和治理能力现代化。
DrugsafetymanagementsysteminChinahasexperiencedfourphasesofdevelopment from planned economy, industrial management, market supervision to social administration. It has transited from early days of low level of performance for"pharmaceutical benefits"to new period of"pharmaceutical welfare".It is of great significance in ensuring drug safety and promoting the development of pharmaceutical industry.In order to deal with issues related to systemic risk of drugs fundamentally, efforts should be made to reconstruct the structure and function of social administration, market adj ustment and government regulation from the level of top design,to have trade-off between commercial and public interests,and to establish long-term mechanism.In the final analysis,it is a social right of all people to get access to drugs of high quality and sufficient amount. Therefore, it is necessary to modernize our drug safety management system and management capacity.