Pharmacovigilance practice and risk control of Traditional Chinese Medicine drugs in China: Current status and future perspective

Zhang, Li; Yan, Jingbo; Liu, Xinmin; Ye, Zuguang; Yang, Xueqing; Meyboom, R.H.B.; Chan, Kelvin; Shaw, Debbie; Duez, Pierre

doi:10.1016/j.jep.2012.01.058

Cited by 172 publications

(123 citation statements)

References 7 publications

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“…5,22 The Food and Drug Administrations in China and the Republic of Korea -like the Pharmaceuticals and Medical Devices Agency in Japan -are supposed to collect reports of adverse events related to all medicines, including herbal ones. 26,27 India, however, has a pharmacovigilance system dedicated to the investigation of traditional ayurvedic drugs.…”

Section: Discussionmentioning

confidence: 99%

Adverse events attributed to traditional Korean medical practices: 1999–2010

Shin

Jeong

Lee

et al. 2013

Bull. World Health Organ.

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Section: Discussionmentioning

confidence: 99%

Adverse events attributed to traditional Korean medical practices: 1999–2010

Shin

Jeong

Lee

et al. 2013

Bull. World Health Organ.

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“…TCHMs have been used to treat diseases for thousands of years in Chinese clinical practice [26,27,28]. For some places in poor financial condition, they have become popular complementary and alternative medicines in the treatment of chronic non-infectious diseases [29]. Today, TCHMs account for 10% of the prescription drugs in China.…”

Section: Discussionmentioning

confidence: 99%

Effect of Maxing Shigan Tang on H1N1 Influenza A Virus-Associated Acute Lung Injury in Mice

et al. 2016

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Objective: This study is aimed at examining the effects of Maxing Shigan Tang (MST) treatment on H1N1-associated acute lung injury (ALI) and exploring the possible mechanism. Material and Methods: Mice were randomly divided into a control group, model group, peroxisomal proliferator activator receptor γ (PPARγ) inhibition group (PPARγ-), PPARγ activation group (PPARγ+), and MST group. Influenza A (H1N1) virus of the Fort Monmouth 1 (FM1) strain was used to induce an ALI mice model. Hematoxylin and eosin staining was performed to investigate the effect of MST treatment on H1N1-associated ALI. Cell apoptosis of lung tissues of each group were conducted through transferase-mediated dUTP nick end-labeling methods. Moreover, the expression level of caspase 3, activity of caspase 3, and serum level of tumor necrosis factor (TNF)-α of each group were also analyzed. Finally, quantitative real-time polymerase chain reaction and Western blotting analysis were carried out to detect angiopoietin-like 4 (ANGPTL4) expression level. Results: We found that mice infected with the FM1 strain of H1N1 influenza A virus developed severe ALI, and MST could improve H1N1-induced ALI. Moreover, MST decreased lung cell apoptosis and reduced the serum content of TNF-α. In addition, MST significantly induced the ANGPTL4 expression in H1N1-induced ALI. Conclusion: MST improves H1N1-associated ALI maybe through targeting ANGPTL4 in mice.

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“…It's obvious that the content of the 2010 GMP compared to the 1998 GMP has transformed from provision-oriented to human-oriented. Provisions about the management and supervision of drugs' quality has been enhanced as the principle of GMP tended to pay more attention to QRM, such as the items about accuracy of qualitative and quantitative methods, the quality control standards were adjusted (Zhang et al, 2012). The implementation of CPM GMP should consider the characteristic of TCM to pay more attention to the process control in extraction and storage because of the special medicinal nature of traditional patent medicine differing from the western medicines (Tan, 2008).…”

Section: Discussion Implementation Status Of Gmp For Cpm and Its Implmentioning

confidence: 99%

Implementation status and barriers of good manufacturing practice (GMP) for chinese patent medicine

He¹,

Hu²,

Wang³

2015

Afr. J. Trad. Compl. Alt. Med.

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Background: Safety, quality and effectiveness of Chinese patent medicine (CPM) are highly relevant to the manufacturing process. However, the level of manufacturing practice (GMP) for CPM as implemented in China is less reported in literatures. Therefore, the aim of this paper was to reveal the implementation status of GMP for CPM in China, in terms of implementation principle, implementation content, industrial impacts, and implementation barriers from both macro and micro aspects. Methods: A comprehensive analysis was carried out with archival data and field work at CPM manufacturers. Results: Both implementation principle and content of GMP for CPM in China indicated a transformation from provision-oriented to human-oriented, leaving more flexible operation space to CPM manufacturers. However, poor manufacturing practices may still exist because the implementation of GMP in China is not strict enough to eliminate all the unqualified CPM manufacturers from market. Moreover, compared with international WHO GMP, there are barriers for implementing GMP for CPM, including main deficiencies in quality control management, cost of GMP renovation projects, lack of education and training, and lack of expertise. Conclusion: This paper found that the implementation of GMP for CPM still faced many barriers though GMP had generated some positive impacts on CPM manufacturing. Removal of implementation barriers could be considered, including strengthening personnel competence, improving the quality management system and enhancing the international communication with advanced GMP regulators.

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Pharmacovigilance practice and risk control of Traditional Chinese Medicine drugs in China: Current status and future perspective

Cited by 172 publications

References 7 publications

Adverse events attributed to traditional Korean medical practices: 1999–2010

Adverse events attributed to traditional Korean medical practices: 1999–2010

Effect of Maxing Shigan Tang on H1N1 Influenza A Virus-Associated Acute Lung Injury in Mice

Implementation status and barriers of good manufacturing practice (GMP) for chinese patent medicine

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