Research Progress of Antitumor Pharmacovigilance.
10.3779/j.issn.1009-3419.2022.101.33
- Author:
Wenjuan SUN
1
;
Yang HU
1
;
Yan XU
2
;
Bo ZHANG
1
Author Information
1. Department of Pharmacy, Peking Union Medical College Hospital,
Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
2. Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital,
Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
- Publication Type:Journal Article
- Keywords:
Antitumor drugs;
Monitoring mode;
Pharmacovigilance;
Target
- MeSH:
China;
Humans;
Lung Neoplasms;
Pharmacovigilance
- From:
Chinese Journal of Lung Cancer
2022;25(7):541-545
- CountryChina
- Language:Chinese
-
Abstract:
In 2019, Drug Administration Law of China was first time proposed that the country should establish pharmacovigilance system. In 2021, the first Pharmacovigilance Quality Management Standard of China was released. The proposal and implementation of pharmacovigilance were the initial stage in China, and it needed to improve the aspects of pharmacovigilance include institution, monitoring mechanism and database construction. The number of new diagnosed cancer patients in China ranked first in the world. In recent years, the marketing speed of novel antitumor drugs was accelerated, and there were many clinical trials. Therefore, antitumor pharmacovigilance was imperative. In this article, we summarized pharmacovigilance of the origin, clinical practice objectives, procedures, methods. We described the difficulties in antitumor pharmacovigilance and current characteristics of pharmacovigilance in China, aiming to provide reference for the development of antitumor pharmacovigilance.
.