Analysis on the situation of the evaluation and clinical trials on-site inspection of the innovative drugs which are recommended approved between 2019 and 2021
10.13699/j.cnki.1001-6821.2024.01.030
- VernacularTitle:我国2019年至2021年审评建议批准上市创新药的审评和临床试验现场核查情况分析
- Author:
Hao BAN
1
;
Hui HE
;
Yi-Di LIU
;
Gang ZHOU
Author Information
1. 国家药品监督管理局药品审评中心,北京,100076
- Keywords:
innovative drug;
drug evaluation;
clinical trial;
on-site in-spection
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(1):144-149
- CountryChina
- Language:Chinese
-
Abstract:
The 68 Center for Drug Evaluation recommend approved innovative drugs between 2019 and 2021 evaluation situation was summarized in this article,to analyzes the innovative drugs research and development trend and the influence of the drug evaluation and approval system reform.Meanwhile,after sorting out the clinical trials inspection report,to analyze the clinical trials on-site inspection of innovative drugs,and summarized the common defects,hope to provide reference and suggestions for subsequent innovative drug application and high-quality drug clinical trials.
