GP for Ayurveda Medicines in Europe Ing. Cornelis J.M. Peters · FP7 Health Partnering event 30 May...

FP7 Health Partnering event30 May 2012, Brussels

GP for Ayurveda Medicines in EuropeIng. Cornelis J.M. Peters

International Open University -TASTAM

SME session

Fit for Health and HEALTH-NCP-NET projects are funded by the European Commission

GP for Ayurveda herbal medicines in all the member states of EU.

International Open University for TASTAM in collaboration with European Ayurveda Centre

NL and ICCD India.

Traditional Indian Medicines.

Project idea/ Company expertise


• We have specialized on the treatment of mental health disorders based on Ayurveda.

• We cooperate in research with Wageningen University regarding our herbal medicines.

• We made two films about mental problems called "Mind Walls" to create awareness of this worldwide problem.

Our expertise


Topic

�Cooperation

KeywordsGP, Ayurveda, Natural Medicines,

Prevention, Mental Health disorders


Status Mental Health problems Worldwide

• Our present society shows an alarming increase of psychological problems at people from all layers of society.

• 1 million people commit suicide every year.

• One in four families has at least one member with a mental disorder.

• Last but not least: enormous emotional as well as financial burden on individuals, their families and society as a whole.


Status Mental Health problems Worldwide


Facts and Figures

• The cost of mental health problems in developed countries is estimated to be between 3% and 4% of GNP

• However, mental disorders cost national economies several billion euros, both in terms of expenditures incurred and loss of productivity.

o Source WHOFit for Health and HEALTH-NCP-NET projects are funded by the European Commission

Facts and Figures

• According to the World Health Organization as much as 80% of the world's population depend on traditional medicine and traditional healers for their primary healthcare needs.


What governments worldwide have to

do!

• Need to establish specifically targeted policies, plans and initiatives to promote and support mental health.

• Promote policy recommendations that incorporates traditional medicine into the nation's health care system.


• Ayurveda has so much to tell about prevention!

• With the growing need for a renewal in the primary health care Ayurveda, the Mother of all Medicines might give an important boost to an healthcare that is more caring, equitable, accessible and affordable.

Ayurveda in the nation's health care system


Status Ayurveda in Europe

• Traditional Medicines as Ayurveda are considered herbals.

• Requirement essentially different from that for western medicines.

• Claims are important for regulatory strategy

• You have to prove what you claim.


Marketing Ayurveda in Europe

• For bringing Ayurveda to the European Market there are three major routes.

• Dietery supplement

• Novel food

• Herbal medicine


Dietery supplement

• For dietary supplement, no harmonized regulation in place in Europe

• Each country has its own regulation

• Most relaxed NL, Hungary and UK

• Most strict: Germany


Novel Food

• Novel food directive issued in 1997 (directive 258/97/EU)

• All food ingredients that were not substantially on the EU market before May 1997 are considered to be novel.

• Marketing only possible after a Novel Food approval by at least one EU country.


Novel Food

• A safety dossier is required.

• Non-clinical studies have to be performed with cost easily exceeding €500.000

• Big food companies spend millions of euros on the safety evaluation of novel foods


New EU Herbal medicines regulations

• Each EU member has its own regulations.

• In NL we have the "warenwet"

• 31st March 2004: EU directive 2004/24/EC approved; one set rules for all the EU members.

• Implementation October 2005 with 7 years transition


New EU Herbal medicines regulations

• 23 Sept. 2004: Committee on Herbal Medicine Products (HMPC) established within EMEA. (European Medicine Agency)

• 27 members: one representative from each EU-member

• Independent of Committee for Medicinal Products for Human Use (CHMP

o www.ema.europa.euFit for Health and HEALTH-NCP-NET projects are funded by the European Commission

Tasks HMPC

• Adaption of existing EU-guidelines for Herbal Medicines to new directive.

• Clarification on the requirements mentioned in new directives.

• Preparation of herbal monographs (100 finished)

• Positive list for products with proven efficacy and safety.


Requirement for registration

• General

o Product or corresponding product at least 30 years in medicinal use including at least 15 years within the EU.

o Applicant and registration holder established in the EU

o Manufacturing and control methods similar as for medicines for human use with marker compounds instead of active ingredients.


Registration aspects GP

• Cultivation of plant material according to Good Agricultural Practice

• Quality criteria: follow ICH regulations

• Stability results presented.

• Good Manufacturing Practice (GMP)

• Pharmacological activity of identified constituents.

• Safety - Efficacy - No clinical studies requiredFit for Health and HEALTH-NCP-NET projects are funded by the European Commission

• Quality: full dossier

• Safety: no harmful effects known in literature

• Efficacy: duration of use

The best way for Ayurveda is registration as herbal medicine and preferable to start with single herbs.


Summary

We are searching:

•Universities for research in Ayurveda herbal medicines.

•SME's in Ayurveda herbal medicines productions

•Ayurveda societies/practitioners for their expertise and data providing

•Ayurveda schools/colleges to establish similar courses throughout the EU member states


Our partners

Thank you!

Contact details

International Open University - TASTAM

nonprofit R&D organization

European Ayurveda Centre - SME

THE NETHERLANDS

International Centre for Cultural Development -ICCD

nonprofit R&D organization from INDIA


Thank you!

Contact details

Contact: Ing. Cornelis J.M. [email protected]

[email protected]


GP for Ayurveda Medicines in Europe Ing. Cornelis J.M. Peters · FP7 Health Partnering event 30 May...

Documents

Transcript of GP for Ayurveda Medicines in Europe Ing. Cornelis J.M. Peters · FP7 Health Partnering event 30 May...