对转型时期我国药品监管体制的宏观思考

Macroscopic reflections on China's drug supervision system in transition

法律制度的良好实施以科学的理念和有效的运行体制作为基础。当前,我国药品监管正处于转型时期,亟待建立起以风险规制理念为指导的现代监管体制。首先,需要在横向和纵向两个方面合理配置药品监管机构的职能,避免职能交叠和监管盲区,同时在事前与事中两个维度强化监管;其次,要进一步提升药品监管效能,对内提升监管部门自身能力,对外加强企业自控与行业自律;最后,要通过行政问责制督促药品监管部门依法履行职责,确保公众健康。

The sound implementation of a legal system depends on scientific ideas and an efficient supervision system. Presently, the drug supervision system is a period of transition, with the prospects of establishing a modern supervision system that incorporates the ideals of risk management. To this end, the responsibilities of the drug super- vision agency shall be adjusted horizontally and vertically so as to enhance the efficiency of supervision and to avoid an overlap of functions or supervision vacancy. We should enhance the capacity for governance and cultivate the self- discipline of the industry and associations. The implementation of administrative accountability is necessary to ensure that institutional responsibilities are fulfilled and thereby realize public health.