International risk signal prioritization principles: comparison and implications for scientific regulation of traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20240905.601
- Author:
Rui ZHENG
1
;
Shuo LIU
2
;
Shi-Jia WANG
3
;
He-Rong CUI
4
;
Hai-Bo SONG
2
;
Hong-Cai SHANG
5
Author Information
1. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing 100700, China McMaster University Hamilton L8N 1Y3, Canada.
2. Center for Drug Reevaluation, National Medical Products Administration Beijing 100037, China.
3. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing 100700, China.
4. School of Life Sciences, Beijing University of Chinese Medicine Beijing 100029, China.
5. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing 100700, China Dongfang Hospital, Beijing University of Chinese Medicine Beijing 100078, China.
- Publication Type:English Abstract
- Keywords:
drug interaction;
pharmacovigilance;
risk signals;
safety of traditional Chinese medicine;
traditional Chinese medicine regulatory science
- MeSH:
Humans;
Medicine, Chinese Traditional/standards*;
China;
Drugs, Chinese Herbal/adverse effects*;
United States;
United States Food and Drug Administration
- From:
China Journal of Chinese Materia Medica
2025;50(1):273-277
- CountryChina
- Language:Chinese
-
Abstract:
Signal detection is a critical task in drug safety regulation. However, it inevitably generates irrelevant or false signals, posing challenges for resource allocation by marketing authorization holders. To reasonably assess these signals, different countries have established various principles for prioritizing the evaluation of risk signals. This study systematically compares these principles and finds that the U.S. Food and Drug Administration(FDA) focuses on practical issues, such as identifying drug confusion or drug interactions. However, China's Good Pharmacovigilance Practices and the European Medicines Agency(EMA) emphasize a comprehensive evaluation framework. The Council for International Organizations of Medical Sciences(CIOMS) emphasizes the consistency of multiple data sources, highlighting the reliability of signal evaluation. China practices a multidisciplinary approach combining traditional Chinese and western medicine, and the risk signals related to traditional Chinese medicine(TCM) have unique characteristics, including complex components, cumulative toxicity, specific theoretical foundations, and drug interactions. The different priorities in risk signal evaluation principles across countries suggest that China should strengthen clinical trial research, emphasize corroboration with evidence of multiple sources, and pay particular attention to the risks of drug interactions in the TCM regulatory science. Establishing the risk signal prioritization principles that align with the characteristics of TCM enables more precise and efficient scientific regulation of TCM.
