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. |
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according active substance adjusted standardised aflatoxins analytical Annex assessment bal medicinal products batch-to-batch batches Chapter Chlorogenic acid clinical coated tablets constituents with known content of extractable CPMP DERnative dosage form dossier dry extract Epicatechin ESCOP Essential oil Ethanol European Pharmacopoeia excipients extract preparation extractable matter extraction solvent extracts and herbal Figure fingerprint chromatograms Finzelberg flavonoids folium fructus guidelines herb herbal drug preparation herbal extracts herbal medicinal prod herbal medicinal products herbal starting material herbal teas homeopathy Hyperforin hypericin Hyperoside known therapeutic activity label leaf Legal provisions relating liquid extract maceration manufacturing procedure marker substances marketing authorisation medicinal plants microbial millilitre monographs native extract native herbal drug Note for Guidance percolation pharmaceutical phytotherapy Quality assurance quality of herbal ratio requirements residue root Rutoside safety and efficacy scientific Silibinin Silymarin soft extracts specific spectrum of constituents Stability Testing stances Textbox therapeutically active constituents tinctures tion ucts Valerian root Valerianae radix