Herbal Medicinal Products: Scientific and Regulatory Basis for Development, Quality Assurance and Marketing AuthorisationHerbal medicinal products are becoming more widely accepted as alternatives to medical prescriptions. Many physicians believe that herbal medicinal products are able to beneficially complement or even replace chemical medicines. Recognizing this, European institutions are pushing the harmonization of assessment criteria for herbal medicinal products. However, this kind of reevaluation of herbal medicinal products is combined with increased expectations of physicians, pharmacists, and patients with regard to quality, safety and efficacy. There are often uncertainties about the interpretation of basic terms related to the manufacture and quality of herbal medicinal products. Herbal Medicinal Products clarifies these uncertainties, increasing transparency in the herbal medicinal products market and supporting an adequate scientific discussion related to herbal medicinal products. It offers a complete survey on current scientific knowledge, as well as on legal basic requirements for the development, standardization, and licensing of herbal medicinal products. |
Contents
Annex | 1 |
1 | 28 |
6 | 34 |
Quality assurance of the herbal starting material | 44 |
4 | 63 |
1 | 70 |
4 | 74 |
The European marketing authorisation system | 81 |
4 | 102 |
8 | 113 |
3 | 124 |
8 | 130 |
CPMPCVMP Note for Guidance on Quality of Herbal Medicinal | 135 |
Monographs on herbal drugs and herbal drug preparations published | 149 |
Monographs published by ESCOP 19961999 fascicules 16 | 166 |
3 | 94 |
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Common terms and phrases
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References to this book
Sodeopec: Soaps, Detergents, Oleochemicals and Personal Care Products Luis Spitz No preview available - 2004 |