The Status Quo And Thinking Of Drug Quality And Safety Supervision Methods In China

Medicines are special products for treating people and saving people,and they are closely related to the life and health of each of us.Safeguarding drug safety is seen as a serious political issue and a major economic issue.The party and the government are highly concerned about drug regulation.At present,China's drug review and approval reforms continue to advance,drug research and development and production capacity develop rapidly,better meet the needs of public drug use,drug supervision and management system is increasingly standardized and improved,including the national,provincial,municipal,county level The administrative supervision system,the technical support system focusing on inspection and detection,adverse reaction monitoring,and the legal guarantee system covering all aspects of drug development,production,circulation and use.Although the Chinese government has continuously increased the supervision of drug safety,in recent years,drug safety incidents have emerged in an endless stream.Every time a quality and safety incident occurs,the drug regulatory authorities will be pushed to the public's stove for baking[1].How to strengthen drug safety supervision after listing,improve supervision efficiency,improve supervision effect,and ensure public drug safety have become urgent problems to be studied and solved.This paper analyzes the drug safety supervision methods in China,and collects data information such as drug flight inspection,national drug sampling test,and adverse reaction monitoring in recent years,including:1.Drug flight inspection.Statistics In recent years,the official website of the State Drug Administration has published the inspection of drug flights,specifically analyzing the problems found in flight inspections,and providing reference for drug supervision in the future.2.National drug sampling test,statistics of drug sampling batches,unqualified batches,unqualified rates and exploratory research results within a period of time,and summarize the inspection results.3.Monitoring of adverse drug reactions.Briefly summarize the adverse reaction monitoring work,collate the 2013-2017 annual report on adverse drug reaction monitoring,statistically analyze the adverse drug reaction/incident report,and summarize the risk control measures to provide more targeted drug adverse reaction monitoring for relevant departments in the future.Provide a basis for work.4.Drug complaints and reports.Statistical analysis of drug complaints and reports data for 2010-2017,from the reporting channels,contractors and other aspects of the summary analysis.5.Summarize the relevant laws and regulations,special actions and innovative supervision forms of drug supervision,and evaluate their effects.Through comparative analysis and reference to US safety drug regulatory measures,we finally give suggestions for adapting to China's safety drug regulation:?improve relevant laws and regulations;?establish a healthy development mechanism for pharmaceutical markets,such as:drug enterprise control mechanism,innovative drug development incentives Mechanisms,local drug regulatory mechanisms,etc.;?to curb the illegal production and sale of counterfeit and inferior drugs;?to expand the ability to monitor counterfeit and inferior drugs and information disclosure channels;?to improve the overall quality of drug regulatory teams;?to carry out regulatory policy research;?to strengthen international exchanges and cooperation;?Strengthen the coordination of departments and improve the ability of social co-governance.