我国建立药品上市许可人制度的必要性与可行性分析——基于制度变迁均衡分析模型

Necessity and Feasibility Analysis of Establishing Marketing Authorization Holder System in China:Based on an Institutional Change Demand-Supply Model

目的:探讨我国是否有必要建立药品上市许可人(MAH)制度,及在我国实施该制度是否可行。方法:依托制度变迁理论中的均衡分析模型,分析MAH制度的潜在收益与需求及其建制过程中面临的成本与供给情况,并结合制度弹性进行分析。结果:国内强大的制度需求使建立MAH制度成为必要;政府供给MAH制度的阻力主要在于适应成本和脱序成本;若政府致力于降低这些制度成本,将同时催生更大的内部需求,由此强力推动我国有效实现由合并管理制度向MAH制度的变迁。结论:有必要在我国建立MAH制度,且现阶段允许在我国某些地区先行试点推行MAH制度。

OBJECTIVE： To explore the necessity of establishing marketing authorization holder （MAH） system in China, and the feasibility of MAH system. METHODS： Based on demand-supply model of institutional change theory, the potential profit and demand of MAH system and the cost and supply of system construction were all analyzed, combined with the flexibility of system. RESULTS： The establishment of MAH system was necessary due to strong domestic system demand; adaption cost and disorder cost mainly blocked the implementation of MAH system. If the government gets involved with trying to reduce the system cost, it will at the same time result in greater internal demand, so as to forcefully promote the system to change from combined management system to MAH system in China. CONCLUSIONS： It is necessary to establish MAH system in China. At present, MAH system is permitted to be first piloted in some areas in China.