title: TradReg 2013: regulation of herbal and traditional medicinal products--European and global strategies--international symposium.
abstract: Plants have always been an important source of treatment. The important contribution of phytotherapy became particularly recognised through European Directive 2004/24/EC (Directive 2004/24/EC, 2004), which set up a new Committee dedicated to herbal medicinal products at the European Medicines Agency (EMA). In addition, it created a new status for traditional herbal medicinal products by making possible their simplified "registration" based on plausible level of efficacy. Nearly 10 years after the creation of this new framework, an impressive number of monographs were established. However, implementation remains a challenge. There is also a critical need to encourage innovation and research and to ensure that new pieces of legislation are applied to herbal medicinal products taking due account of their characteristics. This article reflects the concerns and expectations of the European manufacturers of herbal medicines.
authors.affiliation: Association of the European Self-Medication Industry (AESGP), 7 Avenue de Tervuren, B-1040 Brussels, Belgium. Electronic address: o.bua@aesgp.eu.
authors.forename: Hubertus
authors.initials: H
authors.lastname: Cranz
authors.affiliation: Association of the European Self-Medication Industry (AESGP), 7 Avenue de Tervuren, B-1040 Brussels, Belgium.
authors.forename: Christelle
authors.initials: C
authors.lastname: Anquez-Traxler
mesh_terms: D004345:Drug Industry / Q000331:legislation & jurisprudence; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D008519:Medicine, Traditional / Q000592:standards*; D008517:Phytotherapy / Q000592:standards; D028321:Plant Preparations / Q000592:standards*
chemical_list: D028321:Plant Preparations
keywords: European regulatory framework; Herbal medicinal products; Registration; Self-care; Well-established use