GP for Ayurveda Medicines in Europe Ing. Cornelis J.M. Peters

Size: px
Start display at page:

Download "GP for Ayurveda Medicines in Europe Ing. Cornelis J.M. Peters"

Transcription

1 FP7 Health Partnering event 30 May 2012, Brussels SME session GP for Ayurveda Medicines in Europe Ing. Cornelis J.M. Peters International Open University -TASTAM

2 Project idea/ Company expertise 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.

3 Our 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.

4 Topic Cooperation Keywords GP, Ayurveda, Natural Medicines, Prevention, Mental Health disorders

5 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 Fit for Health burden and HEALTH-NCP-NET on projects individuals, are funded by the European Commission their families and society as a whole.

6 Status Mental Health problems Worldwide

7 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 WHO

8 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.

9 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.

10 Ayurveda in 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.

11 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.

12 Marketing Ayurveda in Europe For bringing Ayurveda to the European Market there are three major routes. Dietery supplement Novel food Herbal medicine

13 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

14 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.

15 Novel Food A safety dossier is required. Non-clinical studies have to be performed with cost easily exceeding Big food companies spend millions of euros on the safety evaluation of novel foods

16 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

17 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

18 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.

19 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 o Applicant and registration holder established in the EU Manufacturing and control methods similar as for Fit medicines for Health and HEALTH-NCP-NET for projects human are funded by the European use Commission with marker compounds instead of active ingredients.

20 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 required

21 Summary 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.

22 Our partners 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

23 Contact details Thank you! 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

24 Contact details Thank you! Contact: Ing. Cornelis J.M. Peters

HERBAL MEDICINES: Product Licence To Traditional Herbal Registration in the UK. Presented by: Mariam Aslam

HERBAL MEDICINES: Product Licence To Traditional Herbal Registration in the UK. Presented by: Mariam Aslam HERBAL MEDICINES: Product Licence To Traditional Herbal Registration in the UK Presented by: Mariam Aslam ESCOP European Scientific Cooperative On Phytotheapy (ESCOP) Founded in June 1989 as an umbrella

More information

DIRECTIVE AMENDING FOR TRADITIONAL HERBAL MEDICINAL PRODUCTS DIRECTIVE 2001/83/EC

DIRECTIVE AMENDING FOR TRADITIONAL HERBAL MEDICINAL PRODUCTS DIRECTIVE 2001/83/EC PROF. GIUSEPPE NISTICO Director Institute of Pharmacology University of Rome, Tor Vergata DIRECTIVE AMENDING FOR TRADITIONAL HERBAL MEDICINAL PRODUCTS DIRECTIVE 2001/83/EC RAPPORTEUR: Giuseppe Nisticò

More information

Herbal products: Marketing strategies and legislation

Herbal products: Marketing strategies and legislation Review Article Herbal products: Marketing strategies and legislation Pieter A. Hooyenga, Renger F. Witkamp, Kees Groen Department of Human Nutrition, Wageningen University, Wageningen, The Netherlands

More information

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 01 September 2008 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4

More information

Public Assessment Report Scientific discussion. Echinaforce Forte, tablet. Asp. No:

Public Assessment Report Scientific discussion. Echinaforce Forte, tablet. Asp. No: Public Assessment Report Scientific discussion Echinaforce Forte, tablet Echinacea purpurea (L.) Moench (purple coneflower) herba recens, dry extract (17-34:1) and Echinacea purpurea (L.) Moench (purple

More information

Public Assessment Report Scientific discussion

Public Assessment Report Scientific discussion Public Assessment Report Scientific discussion Cynaramin, oral drops, solution (Peumus boldus Molina, folium, liquid extract, (1:10); Taraxacum officinale Web., radix and herba, liquid extract, (1:17))

More information

The precarious status of! herbal products in the EU

The precarious status of! herbal products in the EU The precarious status of! herbal products in the EU Presentation to the EP Interest Group on CAM 16th November 2010 by The Herbal Working Group of the CAM Stakeholder Group Presenter: Robert Verkerk PhD

More information

Global review of the challenges in use of traditional medicine and WHO perspective

Global review of the challenges in use of traditional medicine and WHO perspective Global review of the challenges in use of traditional medicine and WHO perspective Dr Xiaorui Zhang Coordinator Traditional Medicine Department of Technical Cooperation for Essential Drugs and Traditional

More information

Obstacles in Assessment and Licensing of Medicinal Products from Asian Traditional Medicines in Europe PD Dr. Werner Knöss BfArM

Obstacles in Assessment and Licensing of Medicinal Products from Asian Traditional Medicines in Europe PD Dr. Werner Knöss BfArM Obstacles in Assessment and Licensing of Medicinal Products from Asian Traditional Medicines in Europe PD Dr. Werner Knöss BfArM Traditional Use of Plants Echinacea Matricaria Angelica Ipecacuanha Harpagophytum

More information

Dormeasan, oral drops, solution (Valeriana officinalis L., radix, tincture; Humulus lupulus L., strobulus, tincture)

Dormeasan, oral drops, solution (Valeriana officinalis L., radix, tincture; Humulus lupulus L., strobulus, tincture) Public Assessment Report Scientific discussion Dormeasan, oral drops, solution (Valeriana officinalis L., radix, tincture; Humulus lupulus L., strobulus, tincture) Asp. No: 2008-1029 This module reflects

More information

New Horizons for Vaccine R&D&I in Europe

New Horizons for Vaccine R&D&I in Europe New Horizons for Vaccine R&D&I in Europe Health, Demographic Change and Wellbeing Ruxandra Draghia-Akli MD, PhD Directorate E - Health Research DG - Research & Innovation European Commission Why EU support

More information

Public Assessment Report Scientific discussion

Public Assessment Report Scientific discussion Public Assessment Report Scientific discussion Echinagard, oral drops, solution (Echinacea purpurea (L.) Moench, fresh herb, expressed juice (1.7-2.5:1)) Asp no: 2008-0658 This module reflects the scientific

More information

FRANKFURT SITE TOUR 2017

FRANKFURT SITE TOUR 2017 FRANKFURT SITE TOUR 2017 MEDIA INFORMATION FRANKFURT SITE TOUR 2017 CONTENTS FRANKFURT INSULIN CITY... 4 5 DIABETES BACKGROUNDER... 6 DIABETES STATISTICS... 7 DIABETES MEDICINES... 8 IMAGE BANK... 9 NOTES...

More information

The Regulation of Herbal Medicines in Europe

The Regulation of Herbal Medicines in Europe The Regulation of Herbal Medicines in Europe Chantel Henderson Avena Consultants Ltd, 6 Melville Terrace, Edinburgh, Scotland EH9 3BN Manuscript received : 16.05.2014 Manuscript accepted: 18.06.2014 The

More information

Public Assessment Report Scientific discussion

Public Assessment Report Scientific discussion Public Assessment Report Scientific discussion Helaflex, film-coated tablet (Harpagophytum procumbens (Burch) DC (devil s claw) dried root, dry extract (4.4-5.0:1) ethanol 60 %) SE/H/1561/01/MR This module

More information

Frequently asked questions

Frequently asked questions 13 February 2017 EMA/527628/2011 Rev. 1 Directorate This document provides answers to the most frequently asked questions received by the European Medicines Agency (EMA).If the answer to your question

More information

Public Assessment Report Scientific discussion. Echinacea Friggs, effervescent tablet (Echinacea purpurea fresh herb, dried expressed juice (20-28:1))

Public Assessment Report Scientific discussion. Echinacea Friggs, effervescent tablet (Echinacea purpurea fresh herb, dried expressed juice (20-28:1)) Public Assessment Report Scientific discussion Echinacea Friggs, effervescent tablet (Echinacea purpurea fresh herb, dried expressed juice (20-28:1)) Asp. no: 2008-0557 This module reflects the scientific

More information

Public Assessment Report Scientific discussion

Public Assessment Report Scientific discussion Public Assessment Report Scientific discussion Galexir, oral solution (Cynara scolymus (artichoke) dried leaf / Gentiana lutea (gentian) dried root /Curcuma longa (turmeric) dried rhizome, liquid extract,

More information

Workshop for OIE national Focal Points for Veterinary Products November 2010, Johannesburg, South Africa. Presentation

Workshop for OIE national Focal Points for Veterinary Products November 2010, Johannesburg, South Africa. Presentation Dr. Anja Holm Chair of CVMP, EMA Danish Medicines Agency Copenhagen, DK - Denmark anh@dkma.dk Overview of existing structures relevant for Veterinary Products Regional Structures: Europe European Medicine

More information

Meeting report, September 2005

Meeting report, September 2005 European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use London, 24 October 2005 Doc. Ref. EMEA//322553/2005 COMMITTEE ON HERBAL MEDICINAL PRODUCTS () Meeting report, 19-20 September

More information

JOINT ANH/BENEFYT POSITION PAPER

JOINT ANH/BENEFYT POSITION PAPER JOINT ANH/BENEFYT POSITION PAPER Working collaboratively to maintain the supply of products associated with traditional systems of medicine in Europe from 2011 onwards By Robert Verkerk 1 MSc DIC PhD and

More information

European Medicines Agency COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL

European Medicines Agency COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL European Medicines Agency London, 12 November 2009 Doc. Ref. EMEA/HMPC/67644/2009 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL GUIDELINE ON SELECTION OF TEST MATERIALS FOR GENOTOXICITY TESTING FOR

More information

Global Market Analysis of Herbal Drug Formulations Joshi Nirali B 1 * and M. B. Shankar 2

Global Market Analysis of Herbal Drug Formulations Joshi Nirali B 1 * and M. B. Shankar 2 REVIEW ARTICLE www.ijapc.com e-issn 2350-0204 Global Market Analysis of Herbal Drug Formulations Joshi Nirali B 1 * and M. B. Shankar 2 1 Shri Jagdish Prasad Jhabarmal Tibrewala University, Vidyanagari,

More information

NOVEL MEDICATION FOR NEUROPATHIC PAIN

NOVEL MEDICATION FOR NEUROPATHIC PAIN NOVEL MEDICATION FOR NEUROPATHIC PAIN NRD.E1 a treatment for diabetic related neuropathic pain Novaremed s Dr Eli Kaplan shares research on NRD.E1 and explains how it can help to treat diabetic related

More information

A Pragmatic Approach Towards The Regulation of Botanical Food Supplements

A Pragmatic Approach Towards The Regulation of Botanical Food Supplements A Pragmatic Approach Towards The Regulation of Botanical Food Supplements 1. Botanicals 2. Basic Principles 3. Current Situation 4. Safety 1. Quality standards 2. Inventory of the products on the market

More information

Public Assessment Report Scientific discussion

Public Assessment Report Scientific discussion Public Assessment Report Scientific discussion Harpatinum, capsule, soft Harpagophytum procumbens D.C. / H. zeyheri Decne (Devil s claw), radix, dry extract (4.4-5.0:1), ethanol 60 % (V/V) SE/H/1640/01/DC

More information

Magyar Nemzeti Szívalapítvány Hungarian National Heart Foundation

Magyar Nemzeti Szívalapítvány Hungarian National Heart Foundation Magyar Nemzeti Szívalapítvány Hungarian National Heart Foundation founded by the Hungarian Association of Cardiologists Tax No: Számlaszám/Bank account: Internet 18049471-2-42 11732002-20346146 www.mnsza.hu;

More information

Regulation of Herbal and Traditional Medicines in Germany BfArM in Dialogue - TradReg 2017

Regulation of Herbal and Traditional Medicines in Germany BfArM in Dialogue - TradReg 2017 Regulation of Herbal and Traditional Medicines in Germany BfArM in Dialogue - TradReg 2017 Prof. Dr. Werner Knöss, Dr. Jacqueline Wiesner TradReg2017 Germany September 2017 Page 1 Federal Institute for

More information

The father of Western medicine, Hippocrates (460 BC BC) is known to have used many plants and herbs for medicinal purposes. Hippocrates' use of

The father of Western medicine, Hippocrates (460 BC BC) is known to have used many plants and herbs for medicinal purposes. Hippocrates' use of UNIT 11 INVESTIGATE WESTERN HERBAL PRODUCTS HISTORY OF TRADITIONAL WESTERN HERBAL MEDICINE The father of Western medicine, Hippocrates (460 BC - 377 BC) is known to have used many plants and herbs for

More information

Public Assessment Report Scientific discussion

Public Assessment Report Scientific discussion Public Assessment Report Scientific discussion Hypermin, tablet [Hypericum perforatum L., (St. John s wort) herba recens, dry extract (3.1-4.0:1) ethanol 60 %] Asp. no: 2008-1034 This module reflects the

More information

Industry and globalisation of herbal medicines

Industry and globalisation of herbal medicines TradReg 2017 Bonn 14 September 2017 Industry and globalisation of herbal medicines Dr Hubertus Cranz Director General Association of the European Self-Medication Industry (AESGP) 7 Avenue de Tervuren,

More information

Dutch Life Sciences November 24 th, Erik Dam, CBO

Dutch Life Sciences November 24 th, Erik Dam, CBO Dutch Life Sciences November 24 th, 2016 Erik Dam, CBO Unmet need for food ingredients with clinically proven health benefits Consumers want healthy foods and will pay more for them (Forbes 2015) Global

More information

Herbal medicinal products an area of patient involvement? Steffen Bager, HMPC member

Herbal medicinal products an area of patient involvement? Steffen Bager, HMPC member Herbal medicinal products an area of patient involvement? Steffen Bager, HMPC member Herbal medicinal products in Europe Legislation: Procedures to market access: Classification: Borderline issues: Product

More information

DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. of 31 March 2004

DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. of 31 March 2004 30.4.2004 Official Journal of the European Union L 136/85 DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending, as regards traditional herbal medicinal products,

More information

Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use

Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use IPAR Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use Agnus castus oral drops Tincture of Agnus castus fruit TR2309/017/001 A. Vogel Ireland Limited 28 November 2018 CRN008R68

More information

The Nutrition and Health Claims Regulation

The Nutrition and Health Claims Regulation , The Nutrition and Health Claims Regulation Dealing with the present Planning for the future THE WORKSHOP In May 2012, after years of negotiation, the European Union (EU) finally adopted its Article 13.1

More information

Health Products Regulatory Authority IPAR. Public Assessment Report for a. Traditional Herbal Medicinal Product

Health Products Regulatory Authority IPAR. Public Assessment Report for a. Traditional Herbal Medicinal Product IPAR Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use Ginkgo-Biloba Pharma Nord film-coated tablets Ginkgo dry extract TR 1242/1/1 TR holder Pharma Nord ApS March 2018

More information

JOSEFIEN VENDRIK, QUALITY MANAGER IRENE JONGENELEN, COÖRDINATOR CLINICAL SUPPLIES MANAGEMENT/ SENIOR CLINICAL STUDY MANAGER

JOSEFIEN VENDRIK, QUALITY MANAGER IRENE JONGENELEN, COÖRDINATOR CLINICAL SUPPLIES MANAGEMENT/ SENIOR CLINICAL STUDY MANAGER Food for Thought JOSEFIEN VENDRIK, QUALITY MANAGER IRENE JONGENELEN, COÖRDINATOR CLINICAL SUPPLIES MANAGEMENT/ SENIOR CLINICAL STUDY MANAGER CLINOPS DAG, 12 APRIL 2018 HISTORY OF RESEARCH AND DEVELOPMENT

More information

Moving towards 2020 priorities for Public Health for the years Health and Consumers

Moving towards 2020 priorities for Public Health for the years Health and Consumers Moving towards 2020 priorities for Public Health for the years 2013-20 Health in the MFF 2014-2020 Commission proposal for the Health for Growth Programme 2014-2020 http://ec.europa.eu/health/programme/policy/index_en.htm

More information

GLP in the European Union Ecolabel detergents, GLP and accreditation

GLP in the European Union Ecolabel detergents, GLP and accreditation GLP in the European Union Ecolabel detergents, GLP and accreditation Maik Schmahl Brussels, 25/03/2010 Chemicals Unit Outline What is GLP? How has it developed? The role of the Member States, the European

More information

Overview of comments received on Community herbal monograph on Cucurbita pepo L, semen (EMA/HMPC/136024/2010)

Overview of comments received on Community herbal monograph on Cucurbita pepo L, semen (EMA/HMPC/136024/2010) 20 November 2012 EMA/HMPC/196724/2012 Committee on Herbal Medicinal Products (HMPC) Overview of comments received on Community herbal monograph on Cucurbita pepo L, semen (EMA/HMPC/136024/2010) Table 1:

More information

Ensuring protection of public health and patients in member states: priorities, constraints, opportunities

Ensuring protection of public health and patients in member states: priorities, constraints, opportunities Ensuring protection of public health and patients in member states: priorities, constraints, opportunities Dr. Christa Wirthumer-Hoche AGES Austrian Medicines and Medical Devices Agency Vienna, Austria

More information

Fang-Chi Chang (M.D.,Ph.D.) Center for Drug Evaluation, Taiwan

Fang-Chi Chang (M.D.,Ph.D.) Center for Drug Evaluation, Taiwan Fang-Chi Chang (M.D.,Ph.D.) Center for Drug Evaluation, Taiwan Outline Herbal Medicines in the U.S. Herbal Medicines in EU Herbal Medicines in Australia Herbal Medicines in Asia & Taiwan Regulatory Strategy

More information

Supplementary Table 1 - Grand priority candidates: Ranking based on percentage of votes received from GP-TCM members and external participants

Supplementary Table 1 - Grand priority candidates: Ranking based on percentage of votes received from GP-TCM members and external participants Supplementary Table 1 - Grand priority candidates: based on percentage of votes received from members and external participants Grand Priorities 1 72.4 7-8 48.6 High-quality research to evaluate the quality

More information

EDQM and European Pharmacopoeia: State-of-the-art Science for Tomorrow s Medicines

EDQM and European Pharmacopoeia: State-of-the-art Science for Tomorrow s Medicines EDQM and European Pharmacopoeia: State-of-the-art Science for Tomorrow s Medicines International Conference organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council

More information

15050/15 JS/pm 1 DGB 3B

15050/15 JS/pm 1 DGB 3B Council of the European Union Brussels, 7 December 2015 (OR. en) 15050/15 SAN 427 OUTCOME OF PROCEEDINGS From: General Secretariat of the Council On: 7 December 2015 To: Delegations No. prev. doc.: 14391/1/15

More information

Potential Grounds for Revocation of a Traditional Herbal Registration

Potential Grounds for Revocation of a Traditional Herbal Registration Potential Grounds for Revocation of a Traditional Herbal Registration By Dr Rosanna Cooper In this article we will be exploring the potential grounds for revocation of the Traditional Herbal Registration

More information

Dagmar Roth-Behrendt Vice-President of the European Parliament

Dagmar Roth-Behrendt Vice-President of the European Parliament 1 Dagmar Roth-Behrendt Vice-President of the European Parliament Herbal medicinal products: new Committee & European dimension Meeting on 23 September 2004 at the European Medicines Agency (EMEA) in London

More information

Pharmaceuticals Working Group Output Recommendations. Dr Oliver Werner & Vd J Pandey Chair & Co Chair

Pharmaceuticals Working Group Output Recommendations. Dr Oliver Werner & Vd J Pandey Chair & Co Chair Pharmaceuticals Working Group Output Recommendations Dr Oliver Werner & Vd J Pandey Chair & Co Chair Focus Areas Good Manufacturing Practices Pharmacopoeia Standards Issues related to establishing contact

More information

Welcome Note by Dr. Helge Braun, Parliamentary State Secretary

Welcome Note by Dr. Helge Braun, Parliamentary State Secretary Welcome Note by Dr. Helge Braun, Parliamentary State Secretary German Federal Ministry of Education and Research on the occasion of ERA-Net NEURON Final Conference October-27, 2011 Berlin, Germany Es gilt

More information

COMMISSION OF THE EUROPEAN COMMUNITIES

COMMISSION OF THE EUROPEAN COMMUNITIES COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 22.12.2008 COM(2008) 882 final REPORT FROM THE COMMISSION TO THE COUNCIL, THE EUROPEAN PARLIAMENT, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE

More information

Improvising Claims. - Dr. R. B. Smarta

Improvising Claims. - Dr. R. B. Smarta Improvising Claims - Dr. R. B. Smarta Labelling is usually perceived as an important aspect in informing the consumers about the contents of food/nutraceuticals in the finished products. Claims allow the

More information

Public Assessment Report Scientific discussion. Ginsana, oral solution. Asp.no.:

Public Assessment Report Scientific discussion. Ginsana, oral solution. Asp.no.: Läkemedelsverket 2014-04-15 Public Assessment Report Scientific discussion Ginsana, oral solution (Panax ginseng C.A. Meyer, radix, standardised dry extract G115 Pharmaton (0.9-3.9:1, 40% ethanol)) Asp.no.:

More information

Safety Assessment of Botanicals and Botanical Preparations. Dr. Balasubramanian

Safety Assessment of Botanicals and Botanical Preparations. Dr. Balasubramanian Safety Assessment of Botanicals and Botanical Preparations Dr. Balasubramanian Introduction Plant materials and extracts (botanicals) form a major component in indigenous peoples traditional ingredients

More information

Update from FDA Office of Regulatory Affairs

Update from FDA Office of Regulatory Affairs Update from FDA Office of Regulatory Affairs Ellen F. Morrison Assistant Commissioner for Medical Products and Tobacco Operations Office of Regulatory Affairs U.S. Food and Drug Administration 1 The Impact

More information

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 16 March 2006 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU

More information

Regulatory aspects of Herbal Medicinal Products. and Supplements in EU / the Netherlands. Ir. Theo van Rooij

Regulatory aspects of Herbal Medicinal Products. and Supplements in EU / the Netherlands. Ir. Theo van Rooij Regulatory aspects of Herbal Medicinal Products and Supplements in EU / the Netherlands Ir. Theo van Rooij www.rivendell.eu Definitions 1 Medicinal Categories of Herbal Medicinal Products: Traditional

More information

Paediatric Investigation Plans for treatment of osteoporosis

Paediatric Investigation Plans for treatment of osteoporosis Paediatric Investigation Plans for treatment of osteoporosis Presentation to EMA expert meeting 2 June 2014 Presented by: Richard Veselý Scientific officer An agency of the European Union The European

More information

COMMISSION REGULATION (EU) No /.. of XXX

COMMISSION REGULATION (EU) No /.. of XXX EUROPEAN COMMISSION Brussels, XXX [ ] [ ](2013) XXX draft COMMISSION REGULATION (EU) No /.. of XXX amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20

More information

Cancer Control Joint Action, Improving Outcomes for Cancer Patients and the European Cancer Patient s Bill of Rights

Cancer Control Joint Action, Improving Outcomes for Cancer Patients and the European Cancer Patient s Bill of Rights Cancer Control Joint Action, Improving Outcomes for Cancer Patients and the European Cancer Patient s Bill of Rights Second CANCON Stakeholder Forum 12 May 2015 Belgian Ministry of Health, Brussels EQUITY

More information

Traditional Medicines Global Scenario

Traditional Medicines Global Scenario Traditional Medicines Global Scenario Muhammed A. Qayyum PTPMA Role of DRAP in Development of Traditional Medicine Industry in Pakistan Islamabad Feb 13, 2013 Absence of understanding does not warrant

More information

Indian Pharmacopoeia Commission

Indian Pharmacopoeia Commission Indian Pharmacopoeia Commission JP 130 th Anniversary Symposium Tokyo, Japan 15 th Sept, 2016 Dr.G.N.Singh Secretary cum Scientific Director, Overview Indian Pharmaceutical Industry Pharmacopoeia and NFI

More information

THE GLOBAL STRATEGY FOR WOMEN S, CHILDREN S AND ADOLESCENTS HEALTH ( )

THE GLOBAL STRATEGY FOR WOMEN S, CHILDREN S AND ADOLESCENTS HEALTH ( ) THE GLOBAL STRATEGY FOR WOMEN S, CHILDREN S AND ADOLESCENTS HEALTH (2016-2030) SURVIVE THRIVE TRANSFORM AT A GLANCE SURVIVE THRIVE TRANSFORM The Global Strategy for Women s, Children s and Adolescents

More information

Marketing Health and Nutrition: Does it Work?

Marketing Health and Nutrition: Does it Work? Marketing Health and Nutrition: Does it Work? Julie G. Adams Almond Board of California 14 June 2011 1 Case Study in less than 15 minutes! Why demand creation is a must, not an option, for almonds Capitalizing

More information

medicine (CAM): group of practices used Alternative medicine: group of practices used as an Integrative medicine: use of conventional medicine in

medicine (CAM): group of practices used Alternative medicine: group of practices used as an Integrative medicine: use of conventional medicine in Chapter 17: Complementary and Alternative Medicine Approaches to Health Care Complementary and alternative medicine (CAM) is a group of diverse medical and health care systems, practices, and products

More information

Anurag Agarwal Chief Operating Officer Natural Remedies Pvt Ltd. Bangalore

Anurag Agarwal Chief Operating Officer Natural Remedies Pvt Ltd. Bangalore I ndian Herbals Global opportunities Anurag Agarwal Chief Operating Officer Natural Remedies Pvt Ltd. Bangalore Time : Date : 28 th June, 2007 16.00 pm to 17.30 pm Venue: Hotel Marriot, Hyderabad WORLD

More information

Homeopathy: the need for robust evidence to inform consumer choice

Homeopathy: the need for robust evidence to inform consumer choice Homeopathy: the need for robust evidence to inform consumer choice Opening and Introduction: Dame Anne Glover and Thierry Courvoisier Homeopathy and the EU: Robin Fears Homeopathy in Sweden: Dan Larhammar

More information

Filling Research Gaps to meet the Malnutrition Challenge : building evidences

Filling Research Gaps to meet the Malnutrition Challenge : building evidences 1 Filling Research Gaps to meet the Malnutrition Challenge : building evidences 20th meeting of the EC-US Task Force on Biotechnology Research 3-4 June 2010, Barcelona Isabelle de Froidmont-Göertz Unit

More information

Public Assessment Report Scientific discussion. Ginsana, soft capsule. Asp.no.:

Public Assessment Report Scientific discussion. Ginsana, soft capsule. Asp.no.: Läkemedelsverket 2014-04-15 Public Assessment Report Scientific discussion Ginsana, soft capsule (Panax ginseng C.A. Meyer, radix, standardised dry extract G115 Pharmaton (0.9-3.9:1, 40% ethanol)) Asp.no.:

More information

State of provision of Hearing Aids in Europe

State of provision of Hearing Aids in Europe Creating a barrier-free Europe for all hard of hearing citizens State of provision of Hearing Aids in Europe 2018 Report 1 Executive Summary Dear Reader, We are pleased to share the report examining affordability

More information

Boehringer Ingelheim and investment in R&D. Volker Barkmann

Boehringer Ingelheim and investment in R&D. Volker Barkmann Boehringer Ingelheim and investment in R&D Volker Barkmann I. Our Corporation Boehringer Ingelheim in brief Boehringer Ingelheim Center Our headquarters in Ingelheim, Germany Family-owned global corporation

More information

Raising Tobacco Taxes A Summary of Evidence from the NCI-WHO Monograph on the Economics of Tobacco and Tobacco Control

Raising Tobacco Taxes A Summary of Evidence from the NCI-WHO Monograph on the Economics of Tobacco and Tobacco Control Raising Tobacco Taxes A Summary of Evidence from the NCI-WHO Monograph on the Economics of Tobacco and Tobacco Control Jeremias N. Paul Jr. Coordinator, Tobacco Control Economics (TCE) Prevention of Noncommunicable

More information

In what way does the ESM provide financial assistance to countries facing economic crisis?

In what way does the ESM provide financial assistance to countries facing economic crisis? Interview with Klaus Regling, Managing Director of the ESM Published on 4 May 2014 in Phileleftheros (Cyprus) by Dorita Yiannakou In what way does the ESM provide financial assistance to countries facing

More information

New Zealand Government Oversight of Halal Certification of Animal Products Exported from New Zealand Auckland University Asia Dialogue July 2012

New Zealand Government Oversight of Halal Certification of Animal Products Exported from New Zealand Auckland University Asia Dialogue July 2012 New Zealand Government Oversight of Halal Certification of Animal Products Exported from New Zealand Auckland University Asia Dialogue July 2012 Kathy Lloyd Market Access Counsellor www.mpi.govt.nz New

More information

STRATEGIC APPROACH & WORKPLAN 2007

STRATEGIC APPROACH & WORKPLAN 2007 Rare Diseases Europe STRATEGIC APPROACH 2007-2009 & WORKPLAN 2007 Paris, March 2007 www.eurordis.org Contents Our strategic approach 2007 2009 o Eurordis in 2010 o Strategic orientations o Priorities 2007-2009

More information

Import Risk Assessment of Plant Pests The EU Situation

Import Risk Assessment of Plant Pests The EU Situation Import Risk Assessment of Plant Pests The EU Situation Jan Schans, NL Plant Protection Service, Wageningen, NL Chair EFSA Panel on Plant Health AFSSA / EFSA Colloquium, 3 October 2008, Paris 1 Overview

More information

AESGP views. Johannes Koch, Head of European Policy and International Affairs German Medicines Manufacturers' Association BAH. Who is AESGP?

AESGP views. Johannes Koch, Head of European Policy and International Affairs German Medicines Manufacturers' Association BAH. Who is AESGP? The international Generic Drug Regulators Programme (IGDRP): an initiative to further strengthen collaboration, promote regulatory convergence and improve worksharing at a worldwide level EDQM premises

More information

Particular challenges of evaluation of herbal combination products

Particular challenges of evaluation of herbal combination products Particular challenges of evaluation of herbal combination products Reinhard Länger, PhD, Assoc. Prof. Austrian Medicines and Medical Devices Agency (AGES MEA/BASG) Dept. for Herbal, Homeopathic & Veterinary

More information

Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use

Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use IPAR Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use Ginkgoforce Memory & Circulation Ginkgo Tablets Extract (as dry extract) from fresh leaves of Ginkgo biloba (Ginkgo

More information

Draft agreed by HMPC Quality Drafting Group October Adopted by HMPC 12 November 2013

Draft agreed by HMPC Quality Drafting Group October Adopted by HMPC 12 November 2013 3 December 2013 EMA/HMPC/453258/2013 Committee on Herbal Medicinal Products (HMPC) Reflection paper on the use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal

More information

Clinical Trials in Third Countries

Clinical Trials in Third Countries Clinical Trials in Third Countries meeting, 29 January 2015 Presented by Fergus Sweeney European Medicines Agency An agency of the European Union Overview Distribution of clinical trials submitted in support

More information

DSQC Overview. Scott Kuzner, Ph.D. USP Global External Affairs Director

DSQC Overview. Scott Kuzner, Ph.D. USP Global External Affairs Director DSQC Overview Scott Kuzner, Ph.D. USP Global External Affairs Director A multi-stakeholder and cross-sector collaborative aimed at improving the quality and safety of products marketed as dietary supplements.

More information

Worldwide Regulatory Perspective on Herbal Drugs & Herbal formulations

Worldwide Regulatory Perspective on Herbal Drugs & Herbal formulations Dr.Mohan Krishna.,M.Pharm.,Ph.D professor Krishna Teja Pharmacy College Tirupathi Worldwide Regulatory Perspective on Herbal Drugs & Herbal formulations 2 Terminology Herbal Substances are mainly whole,

More information

ii. To support India s trade-related training institutions in strengthening their capacities.

ii. To support India s trade-related training institutions in strengthening their capacities. EU-India Capacity Building Initiative for Trade Development in India - CITD INSTITUTIONAL SUPPORT AND TRAINING REGARDING THE EU DIRECTIVE 2004/24/EC ON HERBAL MEDICINES 0. INTRODUCTION The Project (EU-India

More information

Stockpiling of H5N1 vaccines

Stockpiling of H5N1 vaccines Stockpiling of H5N1 vaccines Norbert W. Hehme EVM Influenza Pandemic Working Group EU-Commission Workshop on Stockpiling of Medicinal Products February 21/22, 2008 European Vaccine Manufacturers 1 (EVM)

More information

Specific Challenges for Orphan Drugs with Paediatric Development

Specific Challenges for Orphan Drugs with Paediatric Development Specific Challenges for Orphan Drugs with Paediatric Development Tsveta Schyns-Liharska, PhD ENRAH Member of the PDCO, EMA Representing Patients and EURORDIS Disclaimer Some of the slides in this presentation

More information

A COMPREHENSION STUDY ON REGULATION OF HERBAL DRUGS IN USA, EUROPEAN UNION AND INDIA

A COMPREHENSION STUDY ON REGULATION OF HERBAL DRUGS IN USA, EUROPEAN UNION AND INDIA A COMPREHENSION STUDY ON REGULATION OF HERBAL DRUGS IN USA, EUROPEAN UNION AND INDIA Available online at www.ijdra.com REVIEW ARTICLE 1 Budhwar Vikaas *, 1 Yadav Sunita, 2 Choudhary Manjusha, 3 Nitesh

More information

Finzelberg s role in developing Successful herbal medicinal products

Finzelberg s role in developing Successful herbal medicinal products Finzelberg s role in developing Successful herbal medicinal products From plants to modern herbals Active Phytopharmaceutical Ingredients Pharma Asia 2017, 22.08.2017 Dr. Rainer Kunz 1 Welcome to the nature

More information

Discussion by HMPC Drafting Group on Quality September Start of public consultation 15 February 2013

Discussion by HMPC Drafting Group on Quality September Start of public consultation 15 February 2013 1 2 3 15 January 2013 EMA/HMPC/13658/2013 Committee on Herbal Medicinal Products (HMPC) 4 5 6 7 Concept paper on use of recovered/recycled solvents in the manufacture of herbal preparations for use in

More information

THE COMPLEX JOURNEY OF A VACCINE PART I The manufacturing chain, regulatory requirements and vaccine availability

THE COMPLEX JOURNEY OF A VACCINE PART I The manufacturing chain, regulatory requirements and vaccine availability THE COMPLEX JOURNEY OF A VACCINE PART I The manufacturing chain, regulatory requirements and vaccine availability International Federation of Pharmaceutical Manufacturers & Associations THE COMPLEX JOURNEY

More information

Health for Humanity 2020 Goals 2

Health for Humanity 2020 Goals 2 2017 for Humanity Report Better for Humanity 2020 s 2 At Johnson & Johnson, we aspire to profoundly change the trajectory of health for humanity. Our for Humanity 2020 s, underpinned by 16 targets, focus

More information

Ciprofloxacin Bluefish (Ciprofloxacin hydrochloride)

Ciprofloxacin Bluefish (Ciprofloxacin hydrochloride) Public Assessment Report Scientific discussion Ciprofloxacin Bluefish (Ciprofloxacin hydrochloride) Asp. no: 2006-1626 - 1628 This module reflects the scientific discussion for the approval of Ciprofloxacin

More information

Horizon Introduction. Alex Harris Medical Research Council

Horizon Introduction. Alex Harris Medical Research Council Horizon 2020 - Introduction Alex Harris Medical Research Council Agenda MRC and Horizon 2020 UK Success Rate (FP7 Health) What is Horizon 2020? The Horizon 2020 Health Challenge NCP support MRC and Horizon

More information

REPORT FROM THE AD HOC WORKING GROUP ON HERBAL MEDICINAL PRODUCTS 1997/1998

REPORT FROM THE AD HOC WORKING GROUP ON HERBAL MEDICINAL PRODUCTS 1997/1998 The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use REPORT FROM THE AD HOC WORKING GROUP ON HERBAL MEDICINAL PRODUCTS 1997/1998 The views presented in this

More information

Public Assessment Report Scientific discussion. Prospan, oral solution (Hedera helix L. folium; dry extract (DER 5-7.

Public Assessment Report Scientific discussion. Prospan, oral solution (Hedera helix L. folium; dry extract (DER 5-7. Public Assessment Report Scientific discussion Prospan, oral solution (Hedera helix L. folium; dry extract (DER 5-7.5:1); ethanol 30%) Asp. no: 2008-0572 This module reflects the scientific discussion

More information

The Safety and Effectiveness of Dietary Supplements

The Safety and Effectiveness of Dietary Supplements Assignment 4 The Safety and Effectiveness of Dietary Supplements In Depth: Supplements Supplements, according to the FDA, are a product containing ingredients like vitamins, minerals, herms, amino acids,

More information

Integrating CAM into EU healthcare systems

Integrating CAM into EU healthcare systems Integrating CAM into EU healthcare systems Workshop Complementary and alternative therapies for patients today and tomorrow European Parliament 16 October 2017 Dr Stéphane Espinosa Consultant Traditional,

More information

EFSA Principles and Tools related to Risk Assessment of Food Enzymes

EFSA Principles and Tools related to Risk Assessment of Food Enzymes EFSA Principles and Tools related to Risk Assessment of Food Enzymes Yi Liu, Scientific Officer FIP unit, EFSA Info Session on Applications Food Enzymes Technical meeting with stakeholders on refinement

More information

WORKABLE REGULATORY FRAMEWORK EUROPEAN PARLIAMENT, BRUSSELS 9 NOVEMBER 2016

WORKABLE REGULATORY FRAMEWORK EUROPEAN PARLIAMENT, BRUSSELS 9 NOVEMBER 2016 SPEECH 9 November 2016 BOTANICAL FOOD SUPPLEMENTS: TOWARDS A WORKABLE REGULATORY FRAMEWORK EUROPEAN PARLIAMENT, BRUSSELS 9 NOVEMBER 2016 Check against delivery. Ladies and Gentlemen, Honourable Mr Arimont,

More information

Guideline on quality of herbal medicinal products 1 /traditional herbal medicinal products

Guideline on quality of herbal medicinal products 1 /traditional herbal medicinal products 31 March 2011 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Committee on Herbal Medicinal Products (HMPC) Guideline on quality of herbal

More information