Pay attention to the safety of innovative drugs developed in China
10.3760/cma.j.cn114015-20231218-00906
- VernacularTitle:关注我国自主研发新药的安全性
- Author:
Zhenwei FANG
1
;
Qi QIU
1
;
Yang LIN
1
Author Information
1. 首都医科大学附属北京安贞医院药事部，北京 100029
- Publication Type:Journal Article
- Keywords:
Pharmacovigilance;
China;
New drugs;
Safety;
Drug monitoring
- From:
Adverse Drug Reactions Journal
2024;26(1):2-5
- CountryChina
- Language:Chinese
-
Abstract:
Along with the reforms of the assessment and approval regime for new drugs in China in recent years, independently researched and developed innovative drugs and conditionally approved drugs in China have been more and more. The pre-market clinical trials, assessment and approval system (especially the conditional approval system), and post-market monitoring and management of new drugs in China are still in a continuous improvement stage. Thus we need to specially pay attention to the safety of innovative drugs that independently developed in China and do a good job in post-marketing safety supervision. More evidence-based information for safe use of this type of medication in patients can be provided through the following aspects: strengthening the drug safety monitoring, conducting systematic evaluation of literature data, widely collecting drug safety data through high-quality real-world research, and conducting in-depth mining of information from drug safety reports.
