Traditional herbal medicines worldwide, from reappraisal to assessment in Europe

Journal of Ethnopharmacology

Volumn 158, Issue PART B, 2014, Pages 498-502

  Van Galen, Emiel ^a  

^a MEDICINES EVALUATION BOARD   (Netherlands)

Author keywords

Ayurveda; Committee on herbal medicinal products; Community herbal monographs; Traditional chinese medicine; Traditional herbal medicinal products

Indexed keywords

HERBACEOUS AGENT; PLANT MEDICINAL PRODUCT;

ARTICLE; CHINESE MEDICINE; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; EUROPE; EUROPEAN UNION; HERBAL MEDICINE; MEDICAL PRACTICE; TRADITIONAL MEDICINE; WORLD HEALTH ORGANIZATION; DRUG LEGISLATION; HUMAN; PHYTOTHERAPY; PROCEDURES; STANDARDS; TIME;

EUROPEAN UNION; HUMANS; LEGISLATION, DRUG; MEDICINE, TRADITIONAL; PHYTOTHERAPY; PLANT PREPARATIONS; TIME FACTORS;

EID: 84915786062     PISSN: 03788741     EISSN: 18727573     Source Type: Journal    
DOI: 10.1016/j.jep.2014.07.013     Document Type: Article

References (13)

1. COM 584 - Communication from the European Commission to the Council and the European Parliament concerning the report on the experience acquired as a result of the applications of the provisions applicable to traditional herbal medicinal products, Brussels, 29-09-2008, COM(2008) 584 final. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0584:FIN:en:PDF
2. CBG-PAR 2012 - College ter beoordeling van geneesmiddelen/Medicines Evaluation Board - Public Assessment Report Diao Xin Xue Kang capsules for oral use. 14-03-2012, http://db.cbg-meb.nl/Pars/h102142.pdf
3. - 2001/83/EC - Directive of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use. Consolidated version, 16-11-2012, http://ec.europa.eu/health/files/eudralex/vol-1/dir-2001-83-consol-2012/dir-2001-83-cons-2012-en.pdf
4. - 2004/24/EC - Directive of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community Code relating to medicinal products for human use. (Official Journal L 136, 30-4-2004, p85-90), http://ec.europa.eu/health/files/eudralex/vol-1/dir-2004-24/dir-2004-24-en.pdf
5. TP. Fan, G. Deal, HL. Koo, D. Rees, H. Sun, S. Chen, JH. Dou, VG. Makarov, ON. Pozharitskaya, AN. Shikov, YS. Kim, YT. Huang, YS. Chang, W. Jia, A. Dias, VCW. Wong, and K. Chan Future development of global regulations of Chinese herbal products Journal of Ethnopharmacology 140 2012 2012 568 586
6. HMPC 2010 - Committee on Herbal Medicinal Products - Guideline on the Declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products. (EMA/HMPC/CHMP/CVMP/287539/2005 rev 1). Published april 2010, http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003272.pdf
7. HMPC-AR 2008 - Committee on Herbal Medicinal Products - HMPC Assessement Report on Foeniculum vulgare Miller subsp, vulgare, var. vulgare, fructus (EMEA/HMPC/137426/2006), published 20-02-2008. http://www.ema.europa.eu/docs/en-GB/document-library/Herbal-HMPC-assessment-report/2009/12/WC500018463.pdf
8. HMPC-OC 2008 - Committee on Herbal Medicinal Products - Overview of comments reveived on the Community herbal monograph on HMPC Assessement Report on Foeniculum vulgare Miller subsp, vulgare, var. vulgare, fructus (EMEA/HMPC/200856/2007), published 20-02-2008. http://www.ema.europa.eu/docs/en-GB/document-library/Herbal-Overview-of-comments-received-during-consultation/2009/12/WC500018456.pdf
9. HMPC-AR 2010 - Committee on Herbal Medicinal Products - HMPC Assessement Report on Curcuma longa L., rhizoma (EMEA/HMPC/456848/2008), published 4-02-2010 http://www.ema.europa.eu/docs/en-GB/document-library/Herbal-HMPC-assessment-report/2010/02/WC500070700.pdf
10. HMPC-QA 2014 - Committee on Herbal Medicinal Products - Questions & Answers on the European framework for (traditional) herbal medicinal products, including those from a "non-European" tradition. (EMA/HMPC/402684/2013), http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and-procedural-guideline/2014/05/WC500166358.pdf
11. NtA Vol.2A - European Commission - Notice to Applicants Volume 2A - Procedures for marketing authorisation, Chapter 3, Community Referral Procedures (Part B), Brussels ENTR/F2/SM D, September 2007. http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a-chap3-rev09-2007-en.pdf
12. WHO 1978 - World Health Organization - The promotion and development of traditional medicine, report of a WHO meeting, Geneva 1978, ISBN 9241206225, http://apps.who.int/medicinedocs/documents/s7147e/s7147e.pdf
13. WHO 2013 - World Health Organization - WHO Traditional Medicine Strategy 2014-2023, Geneva 2013, ISBN 9789241506090. http://apps.who.int/iris/bitstream/10665/92455/1/9789241506090-eng.pdf?ua=1