UM  > 中華醫藥研究院
European regulation model for herbal medicine: The assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in Member States
Qu, Liping1; Zou, Wenjun1; Wang, YiTao2; Wang, Mei3
2018-03-15
Source PublicationPHYTOMEDICINE
ISSN0944-7113
Volume42Pages:219-225
Abstract

Background

The European Union (EU) has created a regulatory framework for herbal medicinal products(HMPs) since the enforcement of Directive 2004/24/EC. Substantial achievements have been made, with 1719 traditional use marketing registrations (TURs) and 859 well-established use marketing authorizations (WEU-MAs) for HMPs granted by the end of 2016. Apparently, the European regulation model has worked out well and in that the essential feature is the use of EU herbal monographs into those granted WEU-MAs and TURs.

Purpose

A systematic analysis of the European regulation model for HMPs and the EU herbal monograph's part of this model are undertaken to assist understanding of the EU legislation particularly for interested parties those from outside EU area, and afterwards, to help in decision-making in the HMPs registration in European market for pharmaceutical companies, as well as in the establishment of legislation in countries with strong traditional use of herbal remedies.

Methods

A search of PubMedScienceDirect, the European Medicines Agency website and the Heads of Medicines Agencies website was conducted (up to December 2017), and the available information on regulation of HMPs in the EU was collected.

Results

The evaluation of applications by National Competent Authorities (NCAs) at a national level together with the assessment of EU monographs by the Committee on Herbal Medicinal Products (HMPC) at the European level constitute the European regulation framework for HMPs. As the scientific opinion about the safety and efficacy of HMPs from HMPC, the EU herbal monographs have been given a constitutional-based meaning to the TURs and WEU-MAs of HMPs and play a supportive function in the marketing procedure in Member States.

Conclusion

The European framework has provided a powerful regulation model for harmonization of scientific assessment and facilitation of product marketing. For the pharmaceutical industries particularly those outside the EU, optimal use of the EU herbal monograph in their marketing procedure in Europe could be of great benefit. Furthermore, this model is well worth learningfrom for other countries and regions outside the EU to help the establishment of legislation in countries with strong traditional use of herbal remedies and contribute to the safe use of traditional herbal medicine.

KeywordEuropean Regulation Model Hmp Eu Monograph Tur Weu-ma
DOIhttp://doi.org/10.1016/j.phymed.2018.03.048
URLView the original
Indexed BySCI
Language英语
WOS Research AreaPlant Sciences ; Pharmacology & Pharmacy ; Integrative & Complementary Medicine
WOS SubjectPlant Sciences ; Chemistry, Medicinal ; Integrative & Complementary Medicine ; Pharmacology & Pharmacy
WOS IDWOS:000429905400025
PublisherELSEVIER GMBH, URBAN & FISCHER VERLAG
The Source to ArticleWOS
Fulltext Access
Citation statistics
Cited Times [WOS]:2   [WOS Record]     [Related Records in WOS]
Document TypeJournal article
CollectionInstitute of Chinese Medical Sciences
Corresponding AuthorZou, Wenjun
Affiliation1.College of Pharmacy, Chengdu University of Traditional Chinese Medicine, No.1166 Liutai Avenue, Wenjiang District, Chengdu 610000, China
2.Institute of Chinese Medical Sciences, University of Macau, Av. Padre Tomás Pereira S.J., Taipa, Macao 999078, China
3.Leiden University European Center for Chinese Medicine and Natural compounds, Institute of Biology, Leiden University, Sylviusweg 72/2333BE, The Netherlands
Recommended Citation
GB/T 7714
Qu, Liping,Zou, Wenjun,Wang, YiTao,et al. European regulation model for herbal medicine: The assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in Member States[J]. PHYTOMEDICINE,2018,42:219-225.
APA Qu, Liping,Zou, Wenjun,Wang, YiTao,&Wang, Mei.(2018).European regulation model for herbal medicine: The assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in Member States.PHYTOMEDICINE,42,219-225.
MLA Qu, Liping,et al."European regulation model for herbal medicine: The assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in Member States".PHYTOMEDICINE 42(2018):219-225.
Related Services
Recommend this item
Bookmark
Usage statistics
Export to Endnote
Google Scholar
Similar articles in Google Scholar
[Qu, Liping]'s Articles
[Zou, Wenjun]'s Articles
[Wang, YiTao]'s Articles
Baidu academic
Similar articles in Baidu academic
[Qu, Liping]'s Articles
[Zou, Wenjun]'s Articles
[Wang, YiTao]'s Articles
Bing Scholar
Similar articles in Bing Scholar
[Qu, Liping]'s Articles
[Zou, Wenjun]'s Articles
[Wang, YiTao]'s Articles
Terms of Use
No data!
Social Bookmark/Share
File name: Qu-2018-European-regulation-model-for-herba.pdf
Format: Adobe PDF
All comments (0)
No comment.
 

Items in the repository are protected by copyright, with all rights reserved, unless otherwise indicated.