| Literature DB >> 25281419 |
Hubertus Cranz1, Christelle Anquez-Traxler2.
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.Keywords: European regulatory framework; Herbal medicinal products; Registration; Self-care; Well-established use
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Year: 2014 PMID: 25281419 DOI: 10.1016/j.jep.2014.09.037
Source DB: PubMed Journal: J Ethnopharmacol ISSN: 0378-8741 Impact factor: 4.360