我国药品GMP监管体系存在问题的研究及思考

Research on Drug GMP Supervision System of China and Recommendations

目的探究当前我国《药品生产质量管理规范》(药品GMP)监管体系存在的问题,提出相应对策建议。方法采用文献研究、实地调研、对比研究等方法,从监管理念、法规体系、检查机构和人员、监督机制和违法惩处措施等层面分析药品GMP监管现状和问题。结果我国药品监管部门对监管理念认识不深,同时存在着指南体系不健全、检查机构建设不统一、兼职检查员管理困难、执法透明度不强、对违法行为的惩处不够灵活等问题。结论我国可借鉴国际先进经验,从树立科学监管理念、协调完善相关法规、加强机构和人员建设、健全执法监督机制和规范违法惩处措施等方面完善GMP监管体系。

OBJECTIVE To analyse problems in supervision system of Good Manufacturing Practice（GMP） for drugs and to propose policy suggestions. METHODS Literature review, field research and comparative study were adopted to analyse current situation and problems from the aspects of supervision idea, regulation system, inspection organization and personel, supervision mechanism and illegal punishment measures, etc. RESULTS Drug administration was not fully aware of supervision concept. And there were problems such as insufficient of guideline, inconformity of institution construction, difficulty of inspector management, low transparency of law enforcement and lack of flexible punishment. CONCLUSION It is suggested to learn from international experiences and establish a scientific supervision concept, harmonize relevant regulations, strengthen construction of institutions and personnel, complete monitor mechanism, specify punishment measures to improve GMP supervision system.