J Ethnopharmacol. 2014 Dec 2;158 Pt B:495-7. doi: 10.1016/j.jep.2014.09.037. Epub 2014 Oct 2.
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.
Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
