The New Attitude of the European Regulatory Authorities About Herbal Medicinal Products

Abstract

In 1997, an ad hoc Herbal Medicinal Products Working Group (HMPWG) was established at the European Medicines Evaluation Agency in order to provide guidance for applicants and prepare recommendations on the criteria for the assessment of quality, safety, and efficacy of herbal medicinal products. The following topics were addressed in a detailed document containing several notes for guidance, comments, or points to consider: Notice to Applicants (presentation and content of the application dossier), quality guidance (agricultural production, requirements of active herbal substances and herbal medicinal products, and Type I and Type II variations), and preclinical and clinical assessment (giving particular emphasis to taking the existing scientific literature into account in order to avoid unnecessary animal tests and clinical trials in humans). Details and implications of these documents are presented here.

This is a preview of subscription content, access via your institution.

References

  1. 1.

    Law J. Making sense of herbal medicines. Scrip Magazine. May 1999;37–39.

    Google Scholar 

  2. 2.

    Biffignandi P. Nutraceuticals and functional foods: a consumer-driven regulatory issue. ESRA Rapporteur. 1999;6(5):24–27.

    Google Scholar 

  3. 3.

    Bloch A, Thomson CA. Position of the American Dietetic Association: Phytochemicals and functional foods. J Nutraceuticals, Functional Med Foods. 1997;1:33–45.

    Article  Google Scholar 

  4. 4.

    Dichek B. Enhancing the effects of nutraceuticals. Scrip Magazine, May 1999, p. 35.

    Google Scholar 

  5. 5.

    Steinhoff B. The contribution of the European Scientific Cooperative on Phytotherapy and World Health Organization monographs. Drug Inf J. 1999;33:17–22.

    Article  Google Scholar 

  6. 6.

    FDA. Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products. Rockville, MD: Food and Drug Administration; May 1998.

    Google Scholar 

  7. 7.

    Artiges A. Pharmacopoeial standards for herbal medicinal products in Europe. European Phytojournal. 1999. (www.ex.ac.uk/phytonet/phytojournal/)

    Google Scholar 

Download references

Author information

Affiliations

Authors

Corresponding author

Correspondence to Paolo M. Biffignandi MD, PhD.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Biffignandi, P.M., Carletto, L. The New Attitude of the European Regulatory Authorities About Herbal Medicinal Products. Ther Innov Regul Sci 34, 801–808 (2000). https://doi.org/10.1177/009286150003400316

Download citation

Key Words

  • Herbal drugs
  • Europe
  • Regulatory affairs
  • European Medicines Evaluation Agency
  • Summary of Product Characteristics