Innovation in Phytotherapy: Is a New Regulation the Feasible Perspective in Europe?

Planta Medica

Volume 82, Issue 7, 1 May 2016, Pages 591-595

Minghetti, P.^a, 

Franzè, S.^a, 

Zaccara, V.^a, 

Raso, F.^b, 

Morazzoni, P.^ac 

 

^a  Docente di Tecnologia, Socioeconomia e Legislazione Farmaceutiche, Direttore della Scuola di Specializzazione in Farmacia Ospedaliera, Dipartimento di Scienze Farmaceutiche, Facoltà di Scienze Del Farmaco, Università degli Studi di Milano, Via G. Colombo 71, Milano, Italy
^b  Loacker Remedia Srl, Egna, Italy
^c  Indena S. P. A., Milano, Italy 

View additional affiliations

View references (14)

Abstract

Classical multicomponent preparations mostly derived from traditional usages in Western and Eastern phytotherapy have been under-evaluated for a long time as potential new pharmaceutical products. The regulatory scenario, in particular at the European level, has only recently considered these aspects proposing harmonized guidelines for the pharmaceutical registration of traditional herbal products. Nevertheless, a specific regulation for innovative products based on the combination of precious knowledge arising from traditional usages and modern scientific advancements is still missing. In this paper, we propose a critical review of the current situation with the specific aim of contributing to create a more favorable regulatory environment for the pharmaceutical registration of new and innovative herbalmedicinal products. © Georg Thieme Verlag KG Stuttgart New York.

Author keywords

herbal medicinal products; innovative herbal medicaments; phytotherapy

ISSN: 00320943 CODEN: PLMEASource Type: Journal Original language: English

DOI: 10.1055/s-0042-104509Document Type: Review

Publisher: Georg Thieme Verlag

References (14)

View in search results format

• Page
 
• • Export |
  • Print |
  • E-mail |
  • Create bibliography

• 
  1

  Newman, D.J., Cragg, G.M.

  Natural products as sources of new drugs over the last 25 years
  (2007) Journal of Natural Products, 70 (3), pp. 461-477. Cited 2246 times.
  doi: 10.1021/np068054v
  

  • View at Publisher
• 
  2

  Morrow, J.K., Tian, L., Zhang, S.

  Molecular networks in drug discovery
  (2010) Critical Reviews in Biomedical Engineering, 38 (2), pp. 143-156. Cited 18 times.
  http://www.dl.begellhouse.com/download/article/3f847ae465084d31/CRB3802%20(143-156).pdf
  

  • View at Publisher
• 
  3

  Gertsch, J.

  Botanical drugs, synergy, and network pharmacology: Forth and back to intelligent mixtures
  (2011) Planta Medica, 77 (11), pp. 1086-1098. Cited 75 times.
  doi: 10.1055/s-0030-1270904
  

  • View at Publisher
• 
  4

  Schmidt, B., Ribnicky, D.M., Poulev, A., Logendra, S., Cefalu, W.T., Raskin, I.

  A natural history of botanical therapeutics
  (2008) Metabolism: Clinical and Experimental, 57 (SUPPL. 1), pp. S3-S9. Cited 83 times.
  doi: 10.1016/j.metabol.2008.03.001
  

  • View at Publisher
• 
  5

  Ramawat, K.G.
  (2009) Herbal Drugs: Ethnomedicine to Modern Medicine. Cited 7 times.
  Berlin, Heidelberg Springer-Verlag
  

  •  
• 
  6

  Silano, V., Coppens, P., Larrañaga-Guetaria, A., Minghetti, P., Roth-Ehrang, R.

  Regulations applicable to plant food supplements and related products in the European Union
  (2011) Food and Function, 2 (12), pp. 710-719. Cited 20 times.
  doi: 10.1039/c1fo10105f
  

  • View at Publisher
• 
  7

  Bilia, A.R.

  Herbal medicinal products versus botanical-food supplements in the european market: State of art and perspectives
  (2015) Natural Product Communications, 10 (1), pp. 125-131.
  http://members.naturalproduct.us/Secure/Issue.aspx?volumeissueid=111
  
• 
  8

  Wolfender, J.-L., Marti, G., Thomas, A., Bertrand, S.

  Current approaches and challenges for the metabolite profiling of complex natural extracts
  (2015) Journal of Chromatography A, 1382, pp. 136-164. Cited 37 times.
  www.elsevier.com/locate/chroma
  doi: 10.1016/j.chroma.2014.10.091
  

  • View at Publisher
• 
  9

  Bilia, A.R.

  Science meets regulation
  (2014) Journal of Ethnopharmacology, (PART B), pp. 487-494. Cited 3 times.
  www.elsevier.com/locate/jethpharm
  doi: 10.1016/j.jep.2014.06.036
  

  • View at Publisher
• 
  10

  Guideline on the Use of the CTD Format in the Preparation of A Registration Application for Traditional Herbal Medicinal Products
  EMA/HMPC/71049/2007, Rev. 2; 2015 Accessed February 22, 2016
  http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/04/WC500185353.pdf
  

  •  
• 
  11

  Knöss, W., Chinou, I.

  Regulation of medicinal plants for public health - European community monographs on herbal substances
  (2012) Planta Medica, 78 (12), pp. 1311-1316. Cited 9 times.
  doi: 10.1055/s-0031-1298578
  

  • View at Publisher
• 
  12

  Botanical Drug Development Guidance for Industry
  Revision 1: August 2015 (Pharmaceutical Quality/CMC) Food and Drug Administration Center for Drug Evaluation and Research (CDER) Accessed February 22, 2016
  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM458484.pdf
  

  •  
• 
  13

  Schmidt, B.M., Ribnicky, D.M., Lipsky, P.E., Raskin, I.

  Revisiting the ancient concept of botanical therapeutics
  (2007) Nature Chemical Biology, 3 (7), pp. 360-366. Cited 157 times.
  doi: 10.1038/nchembio0707-360
  

  • View at Publisher
• 
  14

  Fürst, R., Zündorf, I.

  Evidence-Based Phytotherapy in Europe: Where Do We Stand?
  (2015) Planta Medica, 81 (12-13), pp. 962-967. Cited 3 times.
  http://www.thieme-connect.com/ejournals/toc/plantamedica
  doi: 10.1055/s-0035-1545948
  

  • View at Publisher

  Morazzoni, P.; Docente di Tecnologia, Socioeconomia e Legislazione Farmaceutiche, Direttore della Scuola di Specializzazione in Farmacia Ospedaliera, Dipartimento di Scienze Farmaceutiche, Facoltà di Scienze Del Farmaco, Università degli Studi di Milano, Via G. Colombo 71, Italy; email:paola.minghetti@unimi.it
© Copyright 2016 Elsevier B.V., All rights reserved.