中、美两国药品批发企业市场准入制度比较研究

Comparison of Marketing Authorization System for Drug Wholesale Enterprises between China and America

目的完善我国药品批发企业市场准入制度。方法对中、美两国药品批发企业市场准入制度审查流程和审核内容进行比较。结果我国药品批发企业市场准入制度存在"重审批,轻监管",审查流程繁冗、行政效率偏低,重硬件审批、轻信用审查等问题。结论我国应把GSP的相关规定并入《药品经营许可证》审批中去,变GSP认证为审批后的跟踪检查,同时加强对药品购销记录信息提供方的规制。

Objective To improve the marketing authorization system for domestic drug wholesale enterprises in China. Methods Comparison was performed between American and domestic marketing authorization system for drug wholesale enterprises in terms of examining procedures and contents. Results The domestic marketing authorization system has following disadvantages as putting more emphasis on approval while lacking post-approval management, redundant examining procedures resulting in low administrative efficiency, emphasizing hardware requirements but neglect impotance for credit check. Conclusion The regulatory authorities should merge the GSP regulation into the examining of the Drug Supply Certificate, turn the GSP certification into follow-up inspections, and enhance the regulation of the sale and purchase records provider.