保健医学研究与实践2024，Vol.21Issue(Z2)：292-294,3.DOI:10.11986/j.issn.1673-873X.2024.S2.66
监管科学视角下基于风险启动药品注册临床试验现场核查的新思考
New considerations on risk-based activation of on-site verification for clinical trials in pharmaceutical registration from the perspective of regulatory science
李志华 1孙睿1
作者信息
- 1. 内蒙古自治区药品检查中心,呼和浩特 010010
- 折叠
摘要
Abstract
On-site verification of clinical trials in pharmaceutical registration is crucial for ensuring drug safety and promoting the high-quality development of the pharmaceutical industry.With the rapid global growth of the pharmaceutical sector and rising public expectations for drug quality and safety,regulatory agencies face new challenges.Regulatory science,which provides key theoretical support,plays a vital role in advancing regulatory innovation and effectiveness.Against this back-drop,risk-based activation of on-site verification for clinical trials has become a scientific regulatory method widely con-cerned and adopted by drug regulatory agencies in China and globally.However,practical challenges remain in implementing this approach,such as insufficiently comprehensive risk factor identification and superficial risk model development,which hinder further improvements in regulatory effectiveness.This paper hence explores how to scientifically assess risks in on-site verification of clinical trials and optimize activation criteria from the perspective of regulatory science,a vital issue remai-ning to be resolved.This paper begins with an overview of China's current activation model for on-site verification of clinical trials in pharmaceutical registration,elaborates on the factors involved in the initiation of good clinical practice verification of clinical trials in pharmaceutical registration globally,and proposes a quantifiable inspection risk assessment model along with relevant considerations.关键词
监管科学/风险启动/药品注册/临床试验/现场核查Key words
Regulatory science/Risk-based activation/Pharmaceutical registration/Clinical trials/On-site verification分类
医药卫生引用本文复制引用
李志华,孙睿..监管科学视角下基于风险启动药品注册临床试验现场核查的新思考[J].保健医学研究与实践,2024,21(Z2):292-294,3.
