中国食品药品监管Issue(11)：60-67,8.DOI:10.3969/j.issn.1673-5390.2023.11.007
FDA和EMA基于风险启动药品检查情形概述及对我国的启示
Overview of Risk-Based Drug Inspections by FDA and EMA and Implications for China
摘要
Abstract
China is in the initial stage of implementing the new version of drug registration management measures.Developing a comprehensive and complete drug registration inspection system and mechanism helps standardize the risk-based registration inspection process,improve the scientific and complete development of registration inspection initiation status in China,promote the parallel process of risk-based evaluation and verification,and improve the efficiency of registration review and approval.This article provides a detailed introduction to the situation and risk considerations of risk-based pre-approval inspections by the FDA and the EMA.Based on the current situation of risk-based drug registration inspections in China,it offers references for further improving the selection and procedures of risk-based registration inspection in China.关键词
药品/注册核查/基于风险/启动情形/FDA/EMAKey words
drug/registration inspections/risk-based/initiation status/FDA/EMA分类
药学引用本文复制引用
蔺娟,乔利涛,周刚..FDA和EMA基于风险启动药品检查情形概述及对我国的启示[J].中国食品药品监管,2023,(11):60-67,8.
