Skip to main content
SpringerLink
Log in

Pharmacovigilance for Traditional Chinese Medicinal Drugs in China

  • Chapter
  • First Online:
Pharmacovigilance for Herbal and Traditional Medicines

Abstract

This chapter discusses the development and reform of the pharmacovigilance system of the China National Medical Products Administration (NMPA) over the past 5 years; in particular, it reviews current approaches for pharmacovigilance for Traditional Chinese Medicinal drugs (TCMDs) in China and analyzes risk factors associated with these preparations and products, based on Adverse Drug Reaction (ADR) Information Bulletins (ADRIB) issued by the NMPA. The chapter indicates the challenges faced by the pharmacovigilance system for TCMDs in China and provides examples of possible safety concerns. Suggestions are proposed to enhance pharmacovigilance for TCMDs, including: developing signal detection techniques, active surveillance systems and pharmacoepidemiologic studies, adapted for TCMDs; exploring appropriate pharmacovigilance systems and risk-benefit evaluation models led by detecting signals from the spontaneous reporting system; establishing patient reporting to the spontaneous reporting system; addressing an international standardized system for coding for medical terminologies used in TCM and for TCMDs; strengthening surveillance of prepared slices of Chinese crude drugs (PSCCDs) and healthcare products containing PSCCDs; implementing responsibilities for marketing authorization holders in the whole life cycle for TCMDs in China.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 109.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD 139.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Similar content being viewed by others

References

  1. Zhang L, Yan J, Liu X et al (2012) Pharmacovigilance practice and risk control of traditional Chinese medicine drugs in China: current status and future perspective. J Ethnopharmacol 140(3):519–525. https://doi.org/10.1016/j.jep.2012.01.058

    Article  PubMed  Google Scholar 

  2. Zhang L, Yang X, Deng Y (2009) Liver damage related to Polygonum multiflorumand its preparations: domestic literature review and analysis. China J Chin Mater Med 34(8):2414–2418

    Google Scholar 

  3. Medicines and Healthcare products Regulatory Agency (MHRA) (2014) Banned and restricted herbal ingredients. https://www.gov.uk/government/publications/list-of-banned-or-restricted-herbal-ingredients-for-medicinal-use. Accessed 5 Feb 2020

  4. National Medical Products Administration (2019) Drug Administration Law of the People’s Republic of China (DAL). http://www.nmpa.gov.cn/WS04/CL2076/357712.html. Accessed 20 January 2020

  5. National Medical Products Administration, National Center for ADR Monitoring (2019) Adverse drug reaction reporting system. http://www.cdr-adr.org.cn/drug_1/adrReport_1/. Accessed 5 Feb 2020

  6. National Medical Products Administration, National Center for ADR Monitoring (2019) Direct reporting system for MAH. http://daers.adrs.org.cn/#/login?_k=z0gf96. Accessed 5 Feb 2020

  7. National Medical Products Administration, National Center for ADR Monitoring (2011) National Center for ADR Monitoring spontaneous reporting system for healthcare professionals and marketing authorization holder. http://111.202.232.186/sso/login?service=http%3A%2F%2F111.202.232.186%2FPF%2FcasAuthUser. Accessed 5 Feb 2020

  8. Hou Y, Li X, Wu G et al (2016) National ADR monitoring system in China. Drug Saf 39(11):1043–1051. https://doi.org/10.1007/s40264-016-0446-5

    Article  PubMed  Google Scholar 

  9. Li H, Tan N, Zhuang H et al (2020) Effect of Chinese hospital pharmacovigilance system on the reporting of adverse drug reactions in a hospital. Herald Med 39(2):265–267

    Google Scholar 

  10. Hou Y, Song H, Liu H et al (2019) Practice and discussion on active surveillance by Chinese hospital pharmacovigilance system. Chin J Pharmacovigil 16(4):212–214

    Google Scholar 

  11. The State Administration of Traditional Chinese Medicine (2011) China statistical yearbook of Chinese medicine. http://www.satcm.gov.cn/1987-2010/start.htm. Accessed 5 Feb 2020

  12. Pharmacopoeial Commission of PRC (2017) Pharmacopoeia of the People’s Republic of China. China Medical Science Press, Beijing

    Google Scholar 

  13. The State Council of the PRC (2015) Opinions of the state council on reforming the drug and medical device evaluation and approval system. http://english.www.gov.cn/archive/state_council_gazette/2015/09/10/content_281475187020362.htm. Accessed 25 February 2020

  14. FDA News (2017) China joins ICH as full regulatory member, pledges to implement guidelines. https://www.fdanews.com/articles/182330-china-joins-ich-as-full-regulatory-member-pledges-to-implement-guidelines. Accessed 10 Mar 2020

  15. MOH and China Food and Drug Administration (2011) Adverse drug reaction reporting and monitoring provision. http://www.nmpa.gov.cn/WS04/CL2174/300642.html. Accessed 10 Mar 2020

  16. National Medical Products Administration (2018) Announcement on direct report of ADR by marketing authorization holder. Accessed 25 Feb 2020

    Google Scholar 

  17. National Medical Products Administration, National Center for ADR Monitoring (2019) Announcement on on-line trial operation of electronic E2B (R3) transmission system. http://www.cdr-adr.org.cn/drug_1/zcfg_1/zcfg_zdyz/201912/t20191231_47006.html. Accessed 25 Feb 2020

  18. National Medical Products Administration, National Center for ADR Monitoring (2019) Announcement on issuing guideline on the preparation of annual pharmacovigilance report for MAH (Interim). http://www.cdr-adr.org.cn/tzgg_home/201911/t20191129_46857.html. Accessed 25 Feb 2020

  19. National Medical Products Administration (2019) Administrative provision for imported medicinal materials. http://www.nmpa.gov.cn/WS04/CL2138/373553.html. Accessed 25 Feb 2020

  20. National Medical Products Administration (2018) Technical guidance for clinical trial of TCM new drug based on TCM syndrome theories. http://www.nmpa.gov.cn/WS04/CL2138/331783.html. Accessed 25 Feb 2020

  21. Zhang L, Wong LY, He Y et al (2014) Pharmacovigilance in China: current situation, successes and challenges. Drug Saf 37(10):765–770. https://doi.org/10.1007/s40264-014-0222-3

    Article  PubMed  Google Scholar 

  22. National Medical Products Administration (2018) Guidance for clinical evaluation of drug-induced liver injury (DILI). http://www.nmpa.gov.cn/WS04/CL2138/229510.html. Accessed 25 Feb 2020

  23. National Medical Products Administration (2006) Notification on the requirements and guidance for the printing and distribution of the formats and contents of the for the prescription of traditional Chinese medicine and natural medicine. http://www.nmpa.gov.cn/WS04/CL2196/323564.html. Accessed 25 Feb 2020

  24. Zhang L (2018) Pharmacovigilance of herbal and traditional medicines. In: Bate A (ed) Evidence-based pharmacovigilance: clinical and quantitative aspects. Springer, New York, pp 37–65

    Chapter  Google Scholar 

  25. National Medical Products Administration (2018) Notification on publishing the work programme for strengthening the quality of prepared slices of Chinese crude drugs. http://www.nmpa.gov.cn/WS04/CL2196/330076.html. Accessed 25 Feb 2020

  26. National Medical Products Administration (2020) Notification on procedures and requirements for keeping records of provincial norm for the PSCCMs’ process. http://www.nmpa.gov.cn/WS04/CL2196/374149.html. Accessed 25 Feb 2020

  27. National Medical Products Administration (2020) Annual report for national ADR monitoring. http://www.nmpa.gov.cn/WS04/CL2155/376451.html. Accessed 16 May 2020

  28. Zhang L, Yang X, Cao L (2005) Pondering on current status and development of monitoring on adverse reaction of traditional Chinese medicine in China. Chin J Integr Trad West Med 25(7):581–584

    CAS  Google Scholar 

  29. Zhang L, Ye Z, Ji S (2012) Safety monitoring of traditional Chinese medicine injections: the current status and risk management. World Sci Technol Modern Tradit Chin Med Mater Medica 12(6):845–850

    CAS  Google Scholar 

  30. China Food and Drug Administration (2009) Notification on doing well in the reevaluation of TCM injections. http://www.nmpa.gov.cn/WS04/CL2196/323740.html. Accessed 20 Mar 2020

  31. China Food and Drug Administration (2010) Notice on publication the 7 principals for technical guideline on TCM injection safety re-evaluation concerning production process, quality control clinical study and so on. http://www.ccpie.org/cn/yjxx/yphzp/webinfo/2010/10/1481297440376509.htm. Accessed 20 Mar 2020

  32. National Medical Products Administration (2008) Notification on further strengthening the production, management and clinical rational use of TCMI. http://www.nmpa.gov.cn/WS04/CL2079/333373.html. Accessed 20 Mar 2020

  33. Yan YY, Yang YH, Wang WW et al (2017) Post-marketing safety surveillance of the Salvia miltiorrhiza depside salt for infusion: a real world study. PLoS One 12(1):e0170182. https://doi.org/10.1371/journal.pone.0170182

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  34. Li XX, Zhuo L, Zhang Y et al (2019) The incidence and risk factors for adverse drug reactions related to Tanreqing injection: a large population-based study in China. Front Pharmacol 10:1523. https://doi.org/10.3389/fphar.2019.01523

    Article  PubMed  Google Scholar 

  35. China Food and Drug Administration (2013) Notification on promoting key monitoring of pharmaceuticals manufacturing industries (draft for comments). http://www.nmpa.gov.cn/WS04/CL2101/228805.html. Accessed 20 Mar 2020

  36. Li X, Li H, Deng J et al (2018) Active pharmacovigilance in China: recent development and future perspectives. Eur J Clin Pharmacol 74(7):863–871. https://doi.org/10.1007/s00228-018-2455-z

    Article  PubMed  Google Scholar 

  37. Zhang L, Yang X (2004) Cause analysis and countermeasure of ADR caused by traditional Chinese medicine. China J Tradit Chin Med Pharm 19(8):496–498

    CAS  Google Scholar 

  38. Zhang L, Yang X (2009) Pharmacovigilance idea should be introduced sufficiently into the safety monitoring and evaluation process of Chinese drugs. Chin J Integr Trad West Med 29(9):843–846

    CAS  Google Scholar 

  39. Zhu F, Yang M, Chen W et al (2015) Correlation between toxicity and content of Curculiginis Rhizoma and Epimedii Folium with different compatible proportion. Chin J Exp Tradit Med Formulae 21(5):175–177. https://doi.org/10.13422/j.cnki.syfjx.2015050175

    Article  CAS  Google Scholar 

  40. WHO Regional Office for South-East Asia (2009) The use of herbal medicines in primary health care. WHO Regional Office for South-East Asia. https://apps.who.int/iris/handle/10665/206476

  41. Zhang L, Wang G, Lin R (2009) Analysis and discussion on the pharmacovigilance information and measures of risk control in China (1). Chin Pharm Affairs 23(8):735–739

    Google Scholar 

  42. Zhang L, Wang G, Lin R (2009) Analysis and discussion on the pharmacovigilance information and measures of risk control in China (2). Chin Pharm Affairs 23(9):853–856

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Dongfang Hospital Beijing University of Chinese Medicine, Beijing, China

    Li Zhang

  2. Rollins School of Public Health Emory University, GA, Atlanta, USA

    Tianyi Yang

Authors
  1. Li Zhang
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Tianyi Yang
    View author publications

    You can also search for this author in PubMed Google Scholar

Editor information

Editors and Affiliations

  1. School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand

    Joanne Barnes

Rights and permissions

Reprints and permissions

Copyright information

© 2022 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Zhang, L., Yang, T. (2022). Pharmacovigilance for Traditional Chinese Medicinal Drugs in China. In: Barnes, J. (eds) Pharmacovigilance for Herbal and Traditional Medicines. Adis, Cham. https://doi.org/10.1007/978-3-031-07275-8_23

Download citation

Publish with us

Policies and ethics

Search

Navigation