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...

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Bibliographic Details
Published inDrug information journal Vol. 34; no. 3; pp. 801 - 808
Main Authors Biffignandi, Paolo M., Carletto, Lorella
Format Journal Article
LanguageEnglish
Published Los Angeles, CA SAGE Publications 2000
Springer Nature B.V
Subjects
Agricultural production
Clinical trials
Herbal medicine
Product safety
Quality assessment
Summary of Product Characteristics
Regulatory affairs
Europe
European Medicines Evaluation Agency
Herbal drugs
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Summary: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.
ISSN:2168-4790
0092-8615
2168-4804
2164-9200
DOI:10.1177/009286150003400316