Literature DB >> 25281419

TradReg 2013: regulation of herbal and traditional medicinal products--European and global strategies--international symposium.

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.
Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Keywords:  European regulatory framework; Herbal medicinal products; Registration; Self-care; Well-established use

Mesh:

Substances:

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


  3 in total

Review 1.  Internationalization of Traditional/Complementary Medicine products: market entry as medicine.

Authors:  Jiatong Li; Jianfan Zhu; Hao Hu; Joanna E Harnett; Chi Ieong Lei; Ka Yin Chau; Ging Chan; Carolina Oi Lam Ung
Journal:  Chin Med       Date:  2018-10-11       Impact factor: 5.455

Review 2.  Orchidaceae-Derived Anticancer Agents: A Review.

Authors:  Tomasz Śliwiński; Tomasz Kowalczyk; Przemysław Sitarek; Marta Kolanowska
Journal:  Cancers (Basel)       Date:  2022-01-31       Impact factor: 6.639

3.  The availability and validity of safety information of over the counter herbal products for use in diabetes in Sri Lanka: A cross sectional study.

Authors:  Arjuna Bandara Medagama; Heshan Widanapahirana; Tharindu Prasanga
Journal:  J Intercult Ethnopharmacol       Date:  2015-11-08
  3 in total

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