国外药品经营质量管理规范认证制度的研究

On Certification Systems of Good Supplying Practice Overseas

目的:为完善我国药品经营质量管理规范(GSP)认证制度提出建议。方法:采用文献研究法,比较欧盟、美国、澳大利亚、我国港澳台和世卫组织等国家、地区或组织的GSP或药品分销质量管理规范(GDP)认证管理办法。结果:国外GSP认证在是否强制性认证、认证后监管和检查员培训上都有较大的不同。结论:国内GSP认证需要在现有基础上完善认证管理立法,对药品批发和零售两类企业实行分类管理并逐步引入第三方机制,保证药品经营质量。

Objective： To provide references for the improvement of the GSP certification system in China. Methods： Literature study was conducted. The GSP or GDP certificates in China's Mainland, EU, U.S., Australia, WHO, and China HK, Taiwan and Macao were analyzed comprehensively. Results： There were substantial differences in the compulsiveness of certifications, the supervisiion after certification, and the training of the inspectors. Conclusion： The legislation related to authentication management needs to be improved in domestic GSP certification system. Different management over the pharmaceutical retail and wholesale distributors needs to be provided, and the third-party mechanism needs to be introduced step by step in order to ensure the quality of medicine.