Review and analysis on European Union issue ten years of sampling and testing of centrally authorized products
HUANG Zhi-lu
YANG Yue
Abstract：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.
Keywords：centrally authorised productsEuropean Unionsampling testrisk
Publication Date：2010-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 360-364 )