2016年版《药品经营质量管理规范》实施亟需关注的问题与对策

Problems Existing in the Implementation of the GSP 2016 New Version and Relevant Countermeasures

目的充分预估2016年版《药品经营质量管理规范》(GSP)推行过程中可能出现的各种困难,提出对策和建议,保障我国新版GSP的顺利实施。方法基于我国GSP实施的历程和现状,采用文献研究、历史分析、对比分析等方法开展研究。结果与结论新版GSP的实施可能面临药品追溯体系的建立、第三方物流企业引入、药品经营行业调整等一系列问题,可采取完善实施细则,有效监管第三方物流企业,完善退出机制等措施,以保障GSP的顺利实施。

Objective To predict the difficulties that may exist in the process of carrying out the new version of GSP and to put forward some countermeasures to guarantee the complete implementation of it. Methods Based on the history and current situation of the GSP implementation,the method of literature review,historical analysis,comparative analysis were used to investigate the problems and solutions. Results and Conclusion The implementation of new version of GSP may face the questions in the aspects of drug traceability system,the introduction of third- party logistics companies and the adjustment of drug managing enterprises etc. We should take measures of improving the implementation details,effective regulation of third- party logistics enterprises,and improve the exit mechanism to guarantee the smooth implementation of the new version of GSP.