Enlightenment of the Pharmaceutical Inspection Co-Operation Scheme to Provincial Drug Inspection in China
Objective To improve the management quality of provincial drug inspection in China.Methods With the audit checklist of the Pharmaceutical Inspection Co-Operation Scheme(PIC/S)as a reference,the organization structuring of provincial drug regulatory and inspection in China,formulation method of regulatory plan for post-market drugs,training management systems of inspectors and their gaps were summarized and analyzed based on relevant literature and the official websites of various provincial medical product administrations,and the suggestions for improvement were proposed.Results Currently,there are some differences in the structuring of provincial drug regulatory and inspection organizations in China,and the inspection quality is uneven.There is no unified method for formulating regulatory plan for post-market drugs based on risk.The inspector training management system has problems such as inconsistent training content and unclear assessment methods.Conclusion It is suggested that we should incorporate the system evaluation of drug inspection organizations into the quality system of provincial drug regulatory organizations,and establish a regular system evaluation mechanism to ensure that the inspection quality of different inspection organizations meets the unified standards;establish a unified method for formulating regulatory plan for post-market drugs;improve the inspector training management system,provide a unified basic knowledge training and ability assessment platform,and implement hierarchical management for inspectors.
国家科技期刊平台
NSTL
万方数据
