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Pharmacovigilance practice and risk control of Traditional Chinese Medicine drugs in China: current status and future perspective.
J Ethnopharmacol. 2012 Apr 10; 140(3):519-25.JE

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE

Traditional Chinese Medicine (TCM), including Traditional Chinese Medicine drugs (TCM drugs), has been playing a very important role in health protection and disease control for thousands of years in China. Relying on natural products, mainly of herbal origin, used either as raw materials for decoction, as prepared herbal medicines or as formulated traditional medicines, TCM is still widely accepted by Chinese people, especially for chronic diseases treatment. This extensive use warrants safety measures and so TCM drug safety monitoring and risk management are becoming increasingly important tasks for the Chinese State Food and Drug Administration (SFDA).

METHODS

The Adverse Drug Reaction (ADR) monitoring system in China was established both for western and TCM drugs in 1989 as a voluntary reporting system with a National Center collecting and compiling reports. Serious or multi-case reports on individual TCM drug or formulated products are detailed in the Chinese ADR Information Bulletin to inform the public and Drug Administrative authorities for risk management.

RESULTS

About 10-15% of the ADR reports received by the National Center are related to TCM drugs and mainly pertaining to the formulated products. In certain cases, the suspension of a particular TCM preparation is decided by SFDA China.

CONCLUSION

The model of safety monitoring and risk management of TCM drugs is still under exploration. Indeed, the characteristics and risk factors associated with these drugs require both proper understanding and control of the risk by strengthening standardization of clinical applications, basic science research, quality control in manufacturing, exploration of the actives monitoring methodology and enhancement of international communication and cooperation.

Authors+Show Affiliations

Center for Drug Reevaluation, SFDA, Beijing 100045, China. yty0616@hotmail.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

22374080

Citation

Zhang, Li, et al. "Pharmacovigilance Practice and Risk Control of Traditional Chinese Medicine Drugs in China: Current Status and Future Perspective." Journal of Ethnopharmacology, vol. 140, no. 3, 2012, pp. 519-25.
Zhang L, Yan J, Liu X, et al. Pharmacovigilance practice and risk control of Traditional Chinese Medicine drugs in China: current status and future perspective. J Ethnopharmacol. 2012;140(3):519-25.
Zhang, L., Yan, J., Liu, X., Ye, Z., Yang, X., Meyboom, R., Chan, K., Shaw, D., & Duez, P. (2012). Pharmacovigilance practice and risk control of Traditional Chinese Medicine drugs in China: current status and future perspective. Journal of Ethnopharmacology, 140(3), 519-25. https://doi.org/10.1016/j.jep.2012.01.058
Zhang L, et al. Pharmacovigilance Practice and Risk Control of Traditional Chinese Medicine Drugs in China: Current Status and Future Perspective. J Ethnopharmacol. 2012 Apr 10;140(3):519-25. PubMed PMID: 22374080.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacovigilance practice and risk control of Traditional Chinese Medicine drugs in China: current status and future perspective. AU - Zhang,Li, AU - Yan,Jingbo, AU - Liu,Xinmin, AU - Ye,Zuguang, AU - Yang,Xiaohui, AU - Meyboom,Ronald, AU - Chan,Kelvin, AU - Shaw,Debbie, AU - Duez,Pierre, Y1 - 2012/02/21/ PY - 2011/12/16/received PY - 2012/01/30/revised PY - 2012/01/31/accepted PY - 2012/3/1/entrez PY - 2012/3/1/pubmed PY - 2012/8/2/medline SP - 519 EP - 25 JF - Journal of ethnopharmacology JO - J Ethnopharmacol VL - 140 IS - 3 N2 - ETHNOPHARMACOLOGICAL RELEVANCE: Traditional Chinese Medicine (TCM), including Traditional Chinese Medicine drugs (TCM drugs), has been playing a very important role in health protection and disease control for thousands of years in China. Relying on natural products, mainly of herbal origin, used either as raw materials for decoction, as prepared herbal medicines or as formulated traditional medicines, TCM is still widely accepted by Chinese people, especially for chronic diseases treatment. This extensive use warrants safety measures and so TCM drug safety monitoring and risk management are becoming increasingly important tasks for the Chinese State Food and Drug Administration (SFDA). METHODS: The Adverse Drug Reaction (ADR) monitoring system in China was established both for western and TCM drugs in 1989 as a voluntary reporting system with a National Center collecting and compiling reports. Serious or multi-case reports on individual TCM drug or formulated products are detailed in the Chinese ADR Information Bulletin to inform the public and Drug Administrative authorities for risk management. RESULTS: About 10-15% of the ADR reports received by the National Center are related to TCM drugs and mainly pertaining to the formulated products. In certain cases, the suspension of a particular TCM preparation is decided by SFDA China. CONCLUSION: The model of safety monitoring and risk management of TCM drugs is still under exploration. Indeed, the characteristics and risk factors associated with these drugs require both proper understanding and control of the risk by strengthening standardization of clinical applications, basic science research, quality control in manufacturing, exploration of the actives monitoring methodology and enhancement of international communication and cooperation. SN - 1872-7573 UR - https://www.unboundmedicine.com/medline/citation/22374080/Pharmacovigilance_practice_and_risk_control_of_Traditional_Chinese_Medicine_drugs_in_China:_current_status_and_future_perspective_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-8741(12)00112-2 DB - PRIME DP - Unbound Medicine ER -