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

• Published in: Drug information journal Vol. 34; no. 3; pp. 801 - 808
• Main Authors: Biffignandi, Paolo M., Carletto, Lorella
• Format: Journal Article
• Language: English
• 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

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...