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


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.

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Correspondence to Paolo M. Biffignandi MD, PhD.

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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).

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Key Words

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