Ekor M. The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety. Front Pharmacol. 2014;4:177.

Article  PubMed  PubMed Central  Google Scholar 

Arlt VM, Stiborova M, Schmeiser HH. Aristolochic acid as a probable human cancer hazard in herbal remedies: a review. Mutagenesis. 2002;17(4):265–77.

Article  CAS  PubMed  Google Scholar 

Savage RL, Hill GR, Barnes J, Kenyon SH, Tatley MV. Suspected hepatotoxicity with a supercritical carbon dioxide extract of Artemisia annua in grapeseed oil used in New Zealand. Front Pharmacol. 2019;10:1448.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Ulbricht C, Chao W, Costa D, Rusie-Seamon E, Weissner W, Woods J. Clinical evidence of herb-drug interactions: a systematic review by the natural standard research collaboration. Curr Drug Metab. 2008;9(10):1063–120.

Article  CAS  PubMed  Google Scholar 

Crichton M, Strike K, Isenring E, McCarthy AL, Marx W, Lohning A, et al. “It’s natural so it shouldn’t hurt me”: chemotherapy patients’ perspectives, experiences, and sources of information of complementary and alternative medicines. Complement Ther Clin Pract. 2021;43: 101362.

Article  PubMed  Google Scholar 

Welz AN, Emberger-Klein A, Menrad K. Why people use herbal medicine: insights from a focus-group study in Germany. BMC Complement Altern Med. 2018;18(1):92.

Article  PubMed  PubMed Central  Google Scholar 

Zaffani S, Cuzzolin L, Benoni G. Herbal products: behaviors and beliefs among Italian women. Pharmacoepidemiol Drug Saf. 2006;15(5):354–9.

Article  PubMed  Google Scholar 

Lee EL, Barnes J. Prevalence of use of herbal and traditional medicines. In: Barnes J, editor. Pharmacovigilance for herbal and traditional medicines: advances, challenges and international perspectives. Cham: Springer International Publishing; 2022. p. 15–25.

Chapter  Google Scholar 

Lynch N, Berry D. Differences in perceived risks and benefits of herbal, over-the-counter conventional, and prescribed conventional, medicines, and the implications of this for the safe and effective use of herbal products. Complement Ther Med. 2007;15(2):84–91.

Article  PubMed  Google Scholar 

Linde K, Berner MM, Kriston L. St John’s wort for major depression. Cochrane Database Syst Rev. 2008;2008(4): CD000448.

PubMed  PubMed Central  Google Scholar 

Barnes J, Mills SY, Abbot NC, Willoughby M, Ernst E. Different standards for reporting ADRs to herbal remedies and conventional OTC medicines: face-to-face interviews with 515 users of herbal remedies. Br J Clin Pharmacol. 1998;45(5):496–500.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Bracchi RC, Tseliou F, Copeland L, Routledge PA, Thomas A, Woods F, et al. Public awareness in Wales of the UK Yellow Card scheme for reporting suspected adverse drug reactions. Br J Clin Pharmacol. 2021;87(8):3344–8.

Article  PubMed  Google Scholar 

Walji R, Boon H, Barnes J, Welsh S, Austin Z, Baker GR. Reporting natural health product related adverse drug reactions: is it the pharmacist’s responsibility? Int J Pharm Pract. 2011;19(6):383–91.

Article  PubMed  Google Scholar 

World Health Organization. WHO global report on traditional and complementary medicine. 2019. Geneva: World Health Organization; 2019.

Google Scholar 

European Medicines Agency. Guideline on good pharmacovigilance practices (GVP), Module IX: signal management (Rev 1). Amssterdam: European Medicines Agency; 2017. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-ix-signal-management-rev-1_en.pdf. (Accessed 26 Jun 2025).

US Food and Drug Administration. Collaborative identification, evaluation, and resolution of a newly identified safety signal (NISS). 2020. Available from: https://www.fda.gov/media/137475/download. (Accessed 26 Jun 2025).

Demeke H, Hasen G, Sosengo T, Siraj J, Tatiparthi R, Suleman S. Evaluation of policy governing herbal medicines regulation and its implementation in Ethiopia. J Multidiscip Healthc. 2022;15:1383–94.

Article  PubMed  PubMed Central  Google Scholar 

Ajazuddin, Saraf S. Legal regulations of complementary and alternative medicines in different countries. Pharmacogn Rev. 2012;6(12):154–60.

Article  CAS  PubMed  PubMed Central  Google Scholar 

European Medicines Agency. European Union herbal monograph on Ginkgo biloba L., folium. 2015. Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-ginkgo-biloba-l-folium_en.pdf. (Accessed 26 Jun 2025).

National Center for Complementary and Integrative Health. Health information: ginkgo. 2020. Available from: https://www.nccih.nih.gov/health/ginkgo. (Accessed 26 Jun 2025).

Thakkar S, Anklam E, Xu A, Ulberth F, Li J, Li B, et al. Regulatory landscape of dietary supplements and herbal medicines from a global perspective. Regul Toxicol Pharmacol. 2020;114: 104647.

Article  PubMed  Google Scholar 

Council for International Organizations of Medical Sciences. Practical aspects of signal detection in pharmacovigilance: report of CIOMS Working Group VIII. CRC Press, Boca Raton, Florida, USA. 2010.

Sartori D, Aronson JK, Norén GN, Onakpoya IJ. Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: a scoping review of the global literature. Drug Saf. 2023;46(2):109–20.

Article  PubMed  Google Scholar 

Golder S, Norman G, Loke YK. Systematic review on the prevalence, frequency and comparative value of adverse events data in social media. Br J Clin Pharmacol. 2015;80(4):878–88.

Article  PubMed  PubMed Central  Google Scholar 

Parliament E. Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use. OJEU L. 2004;136:85–90.

Google Scholar 

Aronson JK. Defining “nutraceuticals”: neither nutritious nor pharmaceutical. Br J Clin Pharmacol. 2017;83(1):8–19.

Article  PubMed  Google Scholar 

Norén GN, Hopstadius J, Bate A. Shrinkage observed-to-expected ratios for robust and transparent large-scale pattern discovery. Stat Methods Med Res. 2013;22(1):57–69.

Article  PubMed  Google Scholar 

Sartori D, Aronson JK, Onakpoya IJ. Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature. Syst Rev. 2020;9(1):180.

Article  PubMed  PubMed Central  Google Scholar 

Parliament E. Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to veterinary medicinal products. OJEUl L. 2004;311(28/11):1–66.

Google Scholar 

Lagerlund O, Strese S, Fladvad M, Lindquist M. WHODrug: a global, validated and updated dictionary for medicinal information. Ther Innov Regul Sci. 2020;54(5):1116–22.

Article  PubMed  PubMed Central  Google Scholar 

Dauncey EA, Irving JTW, Allkin R. A review of issues of nomenclature and taxonomy of Hypericum perforatum L and Kew’s Medicinal Plant Names Services. J Pharm Pharmacol. 2019;71(1):4–14.

Article  CAS  PubMed  Google Scholar 

European Medicines Agency. European Union monographs and list entries. 2025. Available from: https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products/european-union-monographs-list-entries. [Accessed 26 Jun 2025].

Silano V, Coppens P, Larrañaga-Guetaria A, Minghetti P, Roth-Ehrang R. Regulations applicable to plant food supplements and related products in the European Union. Food Funct. 2011;2(12):710–9.

Article  CAS  PubMed  Google Scholar 

The United States Pharmacopeial Convention. About the herbal medicines compendium. 2024. Available from: https://hmc.usp.org/about/about-the-herbal-medicines-compendium. (Accessed 26 Jun 2025).

National Institutes of Health, Office of Dietary Supplements. Dietary supplements fact sheets. 2025. Available from: https://ods.od.nih.gov/factsheets/list-all. (Accessed 26 Jun 2025).

Dwyer JT, Bailen RA, Saldanha LG, Gahche JJ, Costello RB, Betz JM, et al. The dietary supplement label database: recent developments and applications. J Nutr. 2018;148:1428S-S1435.

Article  PubMed  PubMed Central  Google Scholar 

Gardner Z, McGuffin M. American Herbal Products Association’s botanical safety handbook. CRC Press, Geneva, Switzerland. 2013.

Google Scholar 

World Health Organization. Evaluating and publicly designating regulatory authorities as WHO listed authorities: policy document. 2021. Available from: https://www.who.int/publications/i/item/9789240023444. (Accessed 26 Jun 2025).

World Health Organization. Good reliance practices in the regulation of medical products: high level principles and considerations. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations, editor. WHO Technical Report Series No 1033, Annex 10. Geneva: World Health Organization; 2021: p. 237–58.

European Commission. A guideline on summary of product characteristics. 2009. Available from: https://health.ec.europa.eu/system/files/2016-11/smpc_guideline_rev2_en_0.pdf. (Accessed 26 Jun 2025).

US Food and Drug Administration. 21 Code of Federal Regulations, Part 201. 1975. Available from: https://www.ecfr.gov/current/title-21/part-201. (Accessed 26 Jun 2025).

Parliament E. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the community code relating to medicinal products for human use. OJEU L. 2004;136:34–57.

Google Scholar 

United States Congress. Dietary supplement health and education Act of 1994 Public Law 103–417 103rd Congress. Public Law. 1994;103:417.

Google Scholar 

Insani WN, Pacurariu AC, Mantel-Teeuwisse AK, Gross-Martirosyan L. Characteristics of drugs safety signals that predict safety related product information update. Pharmacoepidemiol Drug Saf. 2018;27(7):789–96.