Review of the regulations for clinical research in herbal medicines in USA

Tony Yuqi Tang; Fang-zhou Li; Janyne Afseth

doi:10.1007/s11655-014-2024-y

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Review of the regulations for clinical research in herbal medicines in USA

OriginalPaper | Updated：2021-08-27

- Review of the regulations for clinical research in herbal medicines in USA
- Review of the regulations for clinical research in herbal medicines in USA
- 中国结合医学杂志（英文版） 2014年20卷第12期页码：883-893
- Affiliations：
  
  1. Herose Clinical Centre,Singapore,Singapore
  2. Department of Law, School of Humanities, Inner Mongolia University of Technology,Hohhot,China
  3. School of Nursing, Midwifery & Social Care, Faculty of Health, Life & Social Sciences, Edinburgh Napier University, Sighthill Campus, Sighthill Court,Edinburgh,UK
- Author bio：
- Funds：
- DOI：10.1007/s11655-014-2024-y
  中图分类号：
- 纸质出版日期：2014，
  
  网络出版日期：2014-11-27，
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Tang, T.Y., Li, Fz. & Afseth, J. Review of the regulations for clinical research in herbal medicines in USA., Chin. J. Integr. Med. 20, 883–893 (2014). https://doi.org/10.1007/s11655-014-2024-y

Tony Yuqi Tang, Fang-zhou Li, Janyne Afseth. Review of the regulations for clinical research in herbal medicines in USA[J]. Chinese Journal of Integrative Medicine, 2014,20(12):883-893.
Tang, T.Y., Li, Fz. & Afseth, J. Review of the regulations for clinical research in herbal medicines in USA., Chin. J. Integr. Med. 20, 883–893 (2014). https://doi.org/10.1007/s11655-014-2024-y DOI：

Tony Yuqi Tang, Fang-zhou Li, Janyne Afseth. Review of the regulations for clinical research in herbal medicines in USA[J]. Chinese Journal of Integrative Medicine, 2014,20(12):883-893. DOI： 10.1007/s11655-014-2024-y.

摘要

In 2012

USA Food and Drug Administration (FDA) approved 39 new drugs

however

there are only two botanical drugs (one topical and one oral) approved by FDA since the publication of the FDA’s industry guidelines for the botanical drug product in June 2004. The approval shows the Western guideline can be used for herbal medicines

authors investigate current regulation on herbal medicine clinical research

identify challenges conducting clinical trials

and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area. Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials. Authors critically explore case study of the 1st FDA approved botanical drugs

Veregen (sinecatechins)

green tea leaves extract

a topical cream for perianal and genital condyloma. In consideration of current regulation environment in USA

based on the findings and analysis through the literature review and Veregen case study

authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considering in a herbal medicine clinical trial.

Abstract

In 2012

USA Food and Drug Administration (FDA) approved 39 new drugs

however

authors investigate current regulation on herbal medicine clinical research

identify challenges conducting clinical trials

Veregen (sinecatechins)

green tea leaves extract

a topical cream for perianal and genital condyloma. In consideration of current regulation environment in USA

based on the findings and analysis through the literature review and Veregen case study

authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considering in a herbal medicine clinical trial.

关键词

herbal medicineChinese Medicineclinical trialTraditional MedicineComplementary Medicinereview

Keywords

herbal medicineChinese Medicineclinical trialTraditional MedicineComplementary Medicinereview

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