title: Drug safety aspects of herbal medicinal products.
abstract: There are numerous statements in the literature suggesting that the safety of herbal products or herbal medicinal products is inadequately considered. Despite the presence of risk, the potential is commonly underestimated as herbals are considered to be natural substances. It is necessary to consider the different categories of herbal products in the market. On one hand there are authorised herbal medicinal products (HMPs) which have adhered to the requirements to present data on quality, efficacy and safety. On the other hand there are products falling outside the use of marketing authorisations as for remedies. In the European Union (EU), HMPs are subject to an ambitious and comprehensive risk management system as for chemically defined drugs, which react effectively to risk concerns with scientific methods, as has been shown in the past. The established methods of pharmacovigilance and risk management favour the authorisation of herbal preparations for medicinal purposes as proprietary medicinal drugs.
authors.affiliation: Consulting HMP, Brückstraße 11, 69469, Weinheim, Germany, t.wegener@consulting-hmp.de.
authors.forename: T
authors.initials: T
authors.lastname: Wegener
authors.forename: B
authors.initials: B
authors.lastname: Deitelhoff
authors.forename: A
authors.initials: A
authors.lastname: Silber-Mankowsky
mesh_terms: D054316:Biomarkers, Pharmacological; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005062:European Union; D006801:Humans; D008517:Phytotherapy / Q000009:adverse effects*; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D010946:Plants, Medicinal / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D012308:Risk Management; D016896:Treatment Outcome
chemical_list: D054316:Biomarkers, Pharmacological; D010936:Plant Extracts