欧盟发布1998-2007年集中审批药品的抽样检验报告评析

Review and analysis on European Union issue ten years of sampling and testing of centrally authorised products

目的:研究欧盟抽验的特点及对我国的借鉴意义。方法:对欧盟集中审批药品抽验的相关文献和报告进行研究,并对欧盟1998-2007年10年抽验的数据的特点进行分析。结果:欧盟对注射剂的检验频率最高,检验参数选择采用关键参数方法,品种选择采用以风险为基础的抽样方法。结论:欧盟检验程序设计严密,在品种选择、参数选择、检验结果及处理方面有一定的参考价值。

Objective： To research the characteristics of CAP sampling test in European Union（EU） market, and the signification of reference for our country. Methods： Document research methods were used in CAPs sampling test report analysis, and ten years sampling test data were analyzed. Results： EU test injections are the most frequent, test parameters are the critical parameters, and products are selected by risk-based sampling methods. Conclusions： EU test procedure design is rigorous. There are some signification in product selection, parameters selection, test results and follow up action for drug sampling tests.