The Significance of Quality for Efficacy and Safety of Herbal Medicinal Products
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THE SIGNIFICANCE OF QUALITY FOR EFFICACY AND SAFETY OF HERBAL MEDICINAL PRODUCTS WERNERBUSSE,PHD Head, Regulatory and Scientific Affairs, International Division, Dr. Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany
The eficacy and safety of any pharmaceutical product is determined by the compounds (desired and undesired) which it contains. The purpose of quality control is to ensure that each dosage unit of the drug product delivers the same amount of active ingredients and is, as far as possible, free of impurities. As herbal medicinal products are complex mixtures which originate from biological sources, great efforts are necessary to guarantee a constant and adequate quality. By carefully selecting the plant material and a standardized manufacturing process the pattern and concentration of constituents of herbal medicinal products should be kept as constant as possible as this is a prerequisite for reproducible therapeutic results. with the increasing use of herbal products, particularly in the United States, the future worldwide labeling practice for herbal products should adequately address quality aspects. Key Words: Herbal medicinal products; Quality; Safety; Efficacy; Labeling
INTRODUCTION
example, herbal products may be introduced as dietary supplements with very few quality data. In contrast to this, premarket approval, which means the submission of quality, safety, and therapeutic data, is mandatory for the authorization of herbal medicinal products in most European countries. Germany, France, Sweden, Denmark, and Switzerland have established specific national regulations concerning the evaluation of herbal products. Other countries (The Netherlands, the United Kingdom, and Portugal) regulate them in the same way as ordinary pharmaceuticals. In dietary supplement markets such as the United States, herbal products are easily available to the general public. A major drawback of a missing premarket control is that products which contain potentially unsafe herbs or undeclared toxic contaminants or do not contain the labeled amount of constituents may be introduced.
OVER RECENT YEARS, the worldwide interest in herbal products has grown significantly, particularly in the United States. This is not only due to a general trend toward natural products, but also to more available evidence regarding the safety and efficacy of herbal medicinal products. Furthermore, advanced knowledge about their composition has been acquired through the introduction of new analytical techniques. At present, however, there are still large international differences in the regulatory status of herbal medicinal products. In the United States, for
Reprint address: Werner Busse, PhD, Head, Regukdtory and Scientific Affairs, International Division, Dr. Willmar Schwabe Pharmaceuticals, PO Box 410925, D-76209 Karlsruhe, Germany. E-mail: wemer.busse@ schwabe.de.
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Werner Busse
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REGULATION OF HERBAL MEDICINAL PRODUCTS A
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