Lessons learned from filing inspection of FDA to assist quality consistency evaluation of generic drugs
WANG Yang
LI Mei
Abstract：According to the No.44 document issued by the State Council,all generic drugs need to be re-evaluated for their quality consistency with the reference listed drugs (RLDs).The Article 14 of the draft announcement of the issues regarding quality consistency sets rules for filing inspection.The current article hopes to assist the quality consistency evaluation work via introduction and evaluation of the US refuse-to-receive (RTR) standards.The filing inspection standards of FDA include original and generic drugs.According to the severities,the deficiencies can be divided into minor and major ones.The major deficiencies,which can be further divided into CMC (chemistry,manufacturing and controls) and bioequivalence,can lead to RTR.In addition,non-standard electronic common technical document (eCTD) can also delay the filing inspection work.
Keywords：filing inspectiongeneric drugquality consistency evaluation
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2908-2912 )