Thoughts on the pharmacovigilance in traditional Chinese medicine injection enterprises
10.3760/cma.j.cn114015-20221031-01002
- VernacularTitle:关于中药注射剂企业开展药物警戒的思考
- Author:
Dekun LI
1
Author Information
1. 天津天士力之骄药业有限公司药物警戒部，天津 300402
- Publication Type:Journal Article
- Keywords:
Pharmacovigilance;
Injections;
Medicine, Chinese traditional;
Traditional Chinese medicine
- From:
Adverse Drug Reactions Journal
2023;25(5):257-262
- CountryChina
- Language:Chinese
-
Abstract:
In 2021, the National Medical Products Administration issued the"Good Pharmacovigilance Practice"(GVP), which required the marketing authorization holders to establish and continuously improve pharmacovigilance system and to carry out pharmacovigilance activities in a normalized manner. Traditional Chinese medicine was the unique variety in China. Due to its high risk in clinical application, more attention should be paid to the overall planning and coordination of various aspects in the pharmacovigilance, especially for the traditional Chinese medicine injections. Thus by consulting regulations and literature, the possible ideas and suggestions such as establishing organizational structure and equipping professional personnel, improving regulations and systems, streamlining information collection channels, and identifying and evaluating risk signals, etc. were proposed for traditional Chinese medicine injection enterprises in carrying out pharmacovigilance.
