Research and Establishment of the Quality Assessment Standard Method of Cosmetic Adverse Reaction Reporting in China Based on the International ADR Monitoring
Objective:International ADR monitoring has developed for many years,and a mature drug reporting quality assessment method has been formed,but there has never been a scientific,systematic,and quantitative evaluation method for the quality of cosmetics adverse reaction reports,both domestically and internationally. In order to improve the quality of cosmetic adverse reaction report,strengthen the analysis evaluation,the basis of risk early warning,a standard method for assessing the quality of adverse reaction reports for cosmetics was established for the first time by drawing on international experience in monitoring adverse drug reactions. Methods:Based on the international quality assessment method of ADR reporting,this study established and operated the "manual sampling score addition" and "computer case-by-case multiplication weight reduction method",which enabled the method of cosmetics report quality assessment in China to achieve a leap from scratch and from existence to excellence. Results:After the application of the report quality evaluation method,the status quo and level of the report quality across the country were mastered by scoring,and the problems and deficiencies of the monitoring work were found out,and then targeted measures such as formulating technical guidelines and providing training guidance were taken to improve the quality of the report. Conclusion:Adverse reaction report is the foundation of adverse reaction monitoring work. Through quantitatively evaluating report quality,identifying the problems and deficiencies,continuously improving the quality of report,a true,complete and accurate information basis is provided for the subsequent analysis evaluation and risk early warning,which provide strong technical support for China's cosmetics regulation and public health safety.
adverse drug reaction monitoringquality of adverse reaction reports in cosmeticsassessment methodmanual sampling score additioncomputer case-by-case multiplication weight reduction methodpractice and performance
万方数据
维普
