Overview of the registration inspection of innovative drugs approved in 2023
- VernacularTitle:2023年批准上市的创新药药品注册核查情况分析概述
- Author:
Hui HE
1
;
Hao BAN
1
;
Miao WANG
1
;
Yi-di LIU
1
;
Meng CUI
1
;
Li-wei SHI
1
;
Gang ZHOU
1
Author Information
- Publication Type:Journal Article
- Keywords: innovative drugs; drug registration inspection; clinical trial inspection
- From: The Chinese Journal of Clinical Pharmacology 2024;40(24):3662-3666
- CountryChina
- Language:Chinese
- Abstract: Drug registration inspection is one of the main links of drug registration,and also an important support for drug technical evaluation.This paper comprehensively collected and sorted out the on-site inspection of R&D and manufacturing and clinical trials of innovative drugs approved in 2023,analyzed the critical and minor defects of the approved innovative drugs in the on-site inspection of R&D and manufacturing and clinical trials,and summarized the common non-compliance issues of innovative drugs in the R&D and manufacturing process and during the clinical trials,so as to provide references and suggestions for the follow-up research and development of innovative drugs and the high-quality development of clinical trials.
