The New Attitude of the European Regulatory Authorities About Herbal Medicinal Products
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THE NEW ATTITUDE OF THE EUROPEAN REGULATORY AUTHORITIES ABOUT HERBAL MEDICINAL PRODUCTS PAOLOM. BIFFIGNANDI, MD, PHD Societa Italiana Attivita Farmaceutiche, Torino, Italy
LORELLACARLETTO, PHD VI.REL Pharma, Vinovo (Torino), Italy
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. Key Words: Herbal drugs; Europe; Regulatory affairs; European Medicines Evaluation Agency; Summary of Product Characteristics
INTRODUCTION BELIEF IN THE SUPERIORITY of natural and organic remedies, which gained considerable impetus in industrialized countries in recent decades, may be viewed as an outgrowth of the counterculture movement of the 1960s. As a matter of fact, among consumers and health care providers, we still find people who insist that Vitamin C from natural sources is in some way different from and superior to Vitamin C prepared synthetically from glucose. On the other hand, it is well recognized that the scientific advances on biodiversity
Reprint address: Paolo Biffignandi, Societa Italiana Attivita Farmaceutiche, Corso Re Umbeno I, 44,10128 Torino, Italy.
with the screening of biological extracts for novel chemical compounds (not only herbal in origin) can provide leads in the development of new medicines or in a better and more responsible use of older, traditional remedies. There are several issues, however, involved in the licensing of herbal products; these become all the more pressing as the popularity of herbal products grows and the dangers become more apparent (1). Despite a number of definitions, the borderline between medicinal products, cosmetics, and food or dietary supplements is often a “gray area,” sometimes making it difficult to determine into which category a product falls. This is partly because many herbal and other natural remedies are currently marketed under differing regulatory labels, ranging from foods to over-the-counter products,
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Paolo M. BifJignandi and Lorella Carletto
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largely depending on local marketing considerations and taking advantage of a substantial lack of regu
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