past, present and future - koop-phyto.org · capsici fructus capsicum centellae asiaticae herba...

past, present and future

Simon MillsESCOP Secretary

ExeterEngland

[email protected]


founded in Koln in 1989

to “advance the scientific status of phytomedicines and to assist with the

harmonization of their regulatory status at the European level.”harmonization of their regulatory status at the European level.”

“Phytomedicines, or herbal medicinal products, are medicinal products

containing as active ingredients only plants, parts of plants or plant materials, or combinations thereof, whether in the crude or processed state.”


Early achievement:

European Commission BIOMED programme: Determining European standards

for the safe and effective use of phytomedicines: 1993 –1997 for the safe and effective use of phytomedicines: 1993 –1997

involving 21 research centres across Europe in developing protocols for

assessing the efficacy and safety of herbal medicinal products

Helped ESCOP produce the first 50 monographs


Publications and information sharing

www.escop.com


Major international conferences


ESCOP Board meeting


ESCOP Scientific Committee meeting


Definitive consensus dossiers on the practical use of herbal medicinal products

ESCOP monograph skills base:

Scientific Committee members - past and present

� Frédérique Lafforgue France

� Norbert Linnenbrink Switzerland

� Christine Nicolai Germany

� Steffan Palm Sweden

� Alda Pereira da Silva Portugal

� Stephanos Phillianos Greece

� Antonella Riva Italy

� Christel Röhl Switzerland

� Finn Sandberg Sweden

� Georg Seidel Germany

� Georg Schonbeck Austria

� Marie-Line. Abou-Chacra France

� Anna Rita Bilia Italy

� Marie-Catherine Bonjean France

� Peter R Bradley United Kingdom

� Michael R.H. Brautigan Netherlands

� Leon. Brimer Denmark

� Jan G. Bruhn Sweden

� Klements Brühwiler Switzerland

� Pierre Chaumelle France

� Franco Chialva Italy

� Desmond Corrigan Ireland � Georg Schonbeck Austria

� Daniel Semeelen Belgium

� Ekrem Sezik Turkey

� N.M. Sitaras Greece

� Bettina Søholm Denmark

� Wilfied Spincemaille Belgium

� Barbara Steinhoff Germany

� Siegfried Throm Germany

� Frans M. van Dungen Netherlands

� Franco F. Vincieri Italy

� Christine Violon Belgium

� Eckhart Wildi Switzerland

� Martin Willoughby United Kingdom

� Jens K. Wold Norway

� Hein H. Zeylstra United Kingdom

� Desmond Corrigan Ireland

� Jozef G. Corthout Belgium

� Bernd Eberwein Germany

� Veronika Etges Germany

� Marijke Frater Switzerland

� Marion J.M. Gijbels Netherlands

� Alain Groubert France

� Lene Gudiksen Denmark

� Didier Guédon France

� Catherine Harvala Greece

� Ingrid Hook Ireland

� Stephan F.A.J. Horsten Netherlands

� Patricia Jean-Jean France

� Roger Kalbermatten Switzerland

� Bjarne F. Knudsen Denmark

� Liselotte Krenn Austria

� Prof. Robert Anton France

� Prof. Guy Balansard France

� Prof. Pierre Delaveau France

� Prof. Dr. Hans van Dijk Netherlands

� Prof. Catherine Harvala Greece

� Prof. Dr. med Dr. h.c.mult Fritz H. Kemper Germany

Prof. Dr. med Karin Kraft Germany


Supervising Editors - past and present

� Prof. Dr. med Karin Kraft Germany

� Prof. Dr. med Dr. dent Dieter Loew Germany

� Prof. David Phillipson United Kingdom

� Prof. Dr. Reinhard Saller Switzerland

� Prof. Dr. Heinz Schilcher Germany

� Prof. Dr. Otto Sticher Switzerland

� Prof. Franco F. Vincieri Italy

� Prof. Arnold Vlietinck Belgium

� Dr. Jan H. Zwaving Netherlands

� Prof. Dr. Rudolf Bauer Germany

� Prof. Dr. Wolfgang Blaschek Germany

� Dr. Cornelia Bellstedt-Suhr Germany

� Dr. Normann Boblitz Germany

� Dr. Werner Busse Germany

� Prof. Dr. Reinhold Carle Germany


Contributing experts - past and present

� Dr. David Knight United Kingdom

� Dr. Ulrike Kroll Germany

� Dr. Elke Leng-Peschlow Germany

� Patricia Luer Germany

� Prof. Dr. Beat Meier Switzerland

� Dr. Ulrich Mengs Germany

� Dr. Paolo Morazzoni Italy� Prof. Dr. Reinhold Carle Germany

� Dr. Anke Esperester Germany

� Dr. Frits Fischer Netherlands

� Prof. Jacques Fleurentin France

� Dr. Jörg Grünwald Germany

� Dr. Martina Hecker Germany

� Dr. Karl-O. Hiller Germany

� Dr. Wiltrud JuretzekGermany

� Dr. Paolo Morazzoni Italy

� Dr. Orlando Petrini Switzerland

� Christine von Platen Germany

� Dr. Fabio Soldati Switzerland

� Ute Stammwitz Germany

� Dr. Christopher Theurer Germany

� Tankred Wegener Germany

� Dr. Rommert Wijnsma Netherlands

� Prof. Dr. Hilke Winterhoff Germany


the product of over 85 volunteers!


… in more than one language


now to be followed by


… the first supplement – due in August 2009

New ESCOP monographs

� AGRIMONIAE HERBA Agrimony

� ALOE BARBADENSIS Barbados Aloes

� ANGELICAE RADIX Angelica Root

� BALLOTAE NIGRAE HERBA Black Horehound

� CAPSICI FRUCTUS Capsicum

� CENTELLAE ASIATICAE HERBA Centella

� CRATAEGI FRUCTUS Hawthorn Berries

� CUCURBITAE SEMEN Pumpkin Seed

� CURCUMAE XANTHORRHIZAE RHIZOMA Javanese Turmeric

� ECHINACEAE ANGUSTIFOLIAE RADIX Narrow-leaved Coneflower Root� ECHINACEAE ANGUSTIFOLIAE RADIX Narrow-leaved Coneflower Root

� FUMARIAE HERBA Fumitory

� GRAMINIS RHIZOMA Couch Grass Rhizome

� GRINDELIAE HERBA Grindelia

� LAVANDULAE FLOS/AETHEROLEUM Lavender Flower/Oil

� MALVAE FLOS Mallow Flower� MELALEUCAE AETHEROLEUM Tea Tree Oil� MILLEFOLII HERBA Yarrow� OLIBANUM INDICUM Indian Frankincense� PAULLINIAE SEMEN Guarana Seed� PRUNI AFRICANAE CORTEX Pygeum africanum Bark� RATANHIAE RADIX Rhatany Root� ROSAE PSEUDO-FRUCTUS Dog Rose Hip� SILYBI MARIANI FRUCTUS Milk Thistle Fruit� SYMPHYTI RADIX Comfrey Root� VACCINII MACROCARPI FRUCTUS Cranberry� VIOLAE HERBA CUM FLORE Wild Pansy (Flowering Aerial Parts)� VITIS VINIFERAE FOLIUM Red Vine Leaf

Revised ESCOP monographs

� CYNARAE FOLIUM Artichoke Leaf

� ECHINACEAE PALLIDAE RADIX Pale Coneflower Root

� ECHINACEAE PURPUREAE HERBA Purple Coneflower Herb

� ECHINACEAE PURPUREAE RADIX Purple Coneflower Root

� ELEUTHEROCOCCI RADIX Eleutherococcus

� HARPAGOPHYTI RADIX Devil’s Claw Root

� VALERIANAE RADIX Valerian Root

� ZINGIBERIS RHIZOMA Ginger

A first page

Another first page

Yet another first page

A revised first page

ESCOP comments on draft Community Monographs from the Herbal Medicinal

Products Committee at the EMEA

� Aesculus hippocastanum semen

� Althaeae radix

� Harpagophyti radix � Lupuli flos


� Althaeae radix

� Anisi fructus

� Artemisia absinthium herba

� Betulae folium

� Boldo folium

� Calendulae flos

� Echinaceae pallidae radix

� Eleutherococci radix

� Foeniculi amari fructus

� Foeniculi dulcis fructus

� Hamamelis folium

� Lupuli flos

� Meliloti herba

� Melissae folium

� Menthae piperitae folium

� Passiflorae herba

� Rhamni purshianae cortex

� Rusci aculeati rhizoma

� Salicis cortex

� Sambuci flos

� Solidaginis virgaureae herba

� Urticae herba

past, present and future?

20 years on …

the world of herbal medicinal products has changed

The herbal spectrum

Foodstuffs Licensed medicinesFood Supplements Registered medicines

(traditional use)- BORDERLINE -

OTC

- Section 12 -

FSA MHRA

EFSA EMEA

Directive 2001/83/EC




REGULATION 1924/2006

EFSA EMEA

The herbal spectrum



OTC

- Section 12 -‘Botanicals’!

FSA MHRA

EFSA EMEA






EFSA EMEA

A. Licensed medicine?

A. Registered medicine?

C. Unlicensed medicine?

D. Food supplement?

A. Licensed medicine

A. Registered medicine

C. Unlicensed medicine

D. Food supplement




D. Food supplement?




D. Food supplement




D. Food supplement?




D. Food supplement




D. Food supplement?




D. Food supplement




D. Food supplement?




D. Food supplement




D. Food supplement?




D. Food supplement

The herbal spectrum



OTC


FSA MHRA

EFSA EMEA






EFSA EMEA

ESCOP on the herbal spectrum?



OTC


FSA MHRA

EFSA EMEA






EFSA EMEA


From the back cover of the new ESCOP supplement:

Whether the evaluation of a herbal medicine is based on evidence of clinical

efficacy (well-established use) or on the historical use of that product in the efficacy (well-established use) or on the historical use of that product in the

European Community (traditional use) those involved at all levels of the regulatory process need access to detailed, reliable and structured

summaries of the available safety and efficacy data. ESCOP monographs

meet that requirement and offer an invaluable source of scientific information on

herbal medicines to regulators, manufacturers, researchers, health

professionals and numerous others.


Service to quality in herbal medicinal products

Is this the next big agenda?


Service to quality in herbal medicinal products

past, present and future - koop-phyto.org · capsici fructus capsicum centellae asiaticae herba...

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