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					International harmonization focus on the regulatory requirements for quality and safety of herbal medicines

Dr Samvel Azatyan
Department of Technical Collaboration for Essential Drugs and Traditional Medicine World Health Organization Geneva

Technical Briefing Seminar, WHO Headquarters, September 2005

1

What is traditional medicine?
WHO defines traditional medicine as including diverse health practices, approaches, knowledge and beliefs incorporating plant, animal, and/or mineral based medicines, spiritual therapies, manual techniques and exercises which can be used to maintain well-being, as well as to treat, diagnose or prevent illness.

Technical Briefing Seminar, WHO Headquarters, September 2005

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Traditional and Complementary/ Alternative Medicine
Categories of TM/CAM
Main Popular System of TM/CAM
    

Traditional Chinese Medicine Indian Ayurveda Medicine Arabic Unani Medicine Homeopathy Chiropractic

Technical Briefing Seminar, WHO Headquarters, September 2005

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Traditional and Complementary/ Alternative Medicine
Categories of TM/CAM Medication
 

Non-medication

  

Medicinal plants

Mineral materials Animal materials



 

Acupuncture Chiropractic Osteopathy Manual therapies Qigong, Taiji, Yoga Physical, mental and spiritual therapies

Technical Briefing Seminar, WHO Headquarters, September 2005

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Populations using TM/CAM worldwide
Populations in developing countries using traditional medicine for primary health care Ethiopia Benin India Rwanda Tanzania Uganda
90% 70% 70% 70% 60% 60%

Populations in developed countries who have used complementary and alternative medicine at least once

Germany
Canada
70% 49% 48% 42%

80%

France
Australia USA

Technical Briefing Seminar, WHO Headquarters, September 2005

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Global Market of Supplements in 2003
VMS Herbs Sports / Specialty
Source: PhytoPharm Consulting, NBJ, EuroConsult, WBP
6

(Market Volume: US$ 51 Billion)
Total

North America
Europe Asia

7.9
5.6 1.6

3.9
6.9 5.1

4.5
2.5 1.1

16.3
15.0 7.8

Japan South America
Rest of the World

3.5
0.8

2.3
0.6

1.4
0.3

7.2
1.7

1.2 20.6

0.8 19.6
retail prices

0.6 10.4

2.6 50.6

Total

Technical Briefing Seminar, WHO Headquarters, September 2005 in

Increase in Market Sales of Herbal Medicines
$US Millions 660 640

Annual Market Sales of Herbal Medicines for Eight Member States

620
600

637

649

580 560
540 520

571

1999

2000

2001

The 8 member states are : the Kingdom of Bhutan, Canada, the Czech Republic, the Islamic Republic of Iran, the Republic of Madagascar, the Islamic Republic of Pakistan, the Republic of Sudan, the Kingdom of Sweden
Technical Briefing Seminar, WHO Headquarters, September 2005

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Main Difficulties Regarding Regulation Issues of Herbal Medicines
Lack of research data

102 88 81 64 33

Lack of appropriate control mechanisms Lack of education and training

Lack of expertise

Other

Technical Briefing Seminar, WHO Headquarters, September 2005

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WHO Traditional Medicine Strategy 2002-2005
1 2
integrate TM/CAM with national health care systems

Policy:

Safety, efficacy and quality:
provide evaluation, guidance and support for effective regulation

3 4

Access: ensure availability and
affordability of TM/CAM, including essential herbal medicines
promote therapeutically-sound use of TM/CAM by providers and consumers
9

Rational use:

Technical Briefing Seminar, WHO Headquarters, September 2005

Evidence based traditional medicine
WHO traditional medicine resolution request WHO to provide evidence-based information to assist Member States in formulating policy and regulations to control the safety, efficacy and quality aspects. (WHA 56)

Technical Briefing Seminar, WHO Headquarters, September 2005

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Policy







Legal Status of Traditional Medicine and Complementary/Alternative Medicine 2001 WHO Global Survey and Database of National Policy and Regulation of TM/CAM and Herbal Medicines including information from 141 countries, 2004 Summary report of the global survey on national policy on traditional medicine and regulation of herbal medicines 2005 Legal status of manual therapies draft

Technical Briefing Seminar, WHO Headquarters, September 2005

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Number of Member States with Recently Established National Policy on TM/CAM
10 9 8 7 6 5 4 3 2 1 0

31% of respondents have national policy
Number of Countries with National Policy Pending: 55

Before 1990

1990 1991

1992 1993

1994 1995

1996 1997 8

1998 1999 9

2000 2001 7

2002 2003 3
12

2 4 6 Number of5Countries before 1990: 5

Number of Countries Total: 44 Technical Briefing Seminar, WHO Headquarters, September 2005

Number of Member States with Recently Established Herbal Medicines Law or Regulation
18 16 14 12 10 8 6 4 2 0
Before 1986 14 1986 1987 4 1988 1989 5 1990 1991 2 1992 1993 8 1994 1995 7 1996 1997 13 1998 1999 16 2000 2001 9 2002 2003 5

65% of respondents have established herbal medicine law or regulation

Number of Countries before 1986: 14
Number of Countries Total:
Technical Briefing Seminar, WHO Headquarters, September 2005

83
13

Number of Registered Herbal Medicines
20 18 16 14 12 10 8 6 4 2 0
1-50 18 51-100 8 101-200 9 201-300 5 301-500 4 500-1000 4 1000 and above 18

Number of Countries Total: 66
Technical Briefing Seminar, WHO Headquarters, September 2005

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Regulatory status of herbal medicines
Prescription medicines Over the Counter Medicines (O.T.C) Dietary Supplements Self-medication only Herbal Medicines as a separate regulatory category Health Food Functional Food Other No Status 0

50 99 48 39 30 16 10 12 21
20 40 60 80 100 120

Number of Countries

Respondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents
Technical Briefing Seminar, WHO Headquarters, September 2005

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Types of claims allowed for herbal medicines
Medical claims Health claims Nutrient content claims Structure/function claim Other claims No claims can be made according to the law
Respondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents

91

62 50

40

7

5

0

20

40

60

80

100

Number of Countries
16

Technical Briefing Seminar, WHO Headquarters, September 2005

Policy
National capacity-building






A series of workshops on regulation of herbal medicines AFRO 1 AMRO 2 EMRO 2 SEARO 1 EURO 1 WPRO 1 Three Regional guidelines for the minimum requirements for regulation of herbal medicines have been developed. (AFRO, SEARO and EMRO) International Meeting on Integration of TM/CAM into National Health System in November 2005, Geneva

Technical Briefing Seminar, WHO Headquarters, September 2005

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Safety, efficacy and quality
 WHO monographs on selected medicinal
plants Volume 1. 1998 2. 2002 3. in press 4. in drafting WHO consultation will take place on Oct 2005, Italy  Quality control methods for medicinal plant materials 1998  Guidelines for Good Agricultural Practice and Good Collection Practice for medicinal plants (GACP) 2003  WHO guidelines on assessing safety and quality of herbal medicines with reference to contaminants and residues, (in press)

Technical Briefing Seminar, WHO Headquarters, September 2005

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Safety, efficacy and quality
 WHO guidelines on safety
monitoring and pharmacovigilance of herbal medicines in 2004  Updated WHO GMP guidelines for herbal products was finalized in 2005  Guidelines for mark substance selection for quality control of herbal medicines draft WHO consultation took place in June 2005, UAE
Technical Briefing Seminar, WHO Headquarters, September 2005

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WHO documents on clinical reports
Acupuncture: Review and analysis of reports on controlled clinical trials 2002
SARS: clinical trials on treatment using a combination of Traditional Chinese medicine and Western medicine 2004

Homeopathy: review and analysis of reports on controlled clinical trials in press

Technical Briefing Seminar, WHO Headquarters, September 2005

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Rational Use
WHO guidelines for developing consumer information on the proper use of TM/CAM 2004  WHO guidelines for basic training and safety of acupuncture in 1999  Training guidelines for phytotherapies, draft  who can prescribe herbal medicines  who can sell herbal medicines  who can distribute herbal medicines  Training guidelines for manual therapies draft  Chiropractic  Osteopathy  Chinese Tuina  Thai massage etc


Technical Briefing Seminar, WHO Headquarters, September 2005

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Activities in Interregional and Regional level related to safety, efficacy and quality control
 National Capacity Building WHO regional or interregional Training workshop for regulation and quality control: - One in AFRO - One Interregional Training workshop on GACP and GMP for quality control (take place in Sep China)  WHO monograph for GACP of Artemisia annua L WHO consultation in Nan Ning, China 5-7 of July 2005

Technical Briefing Seminar, WHO Headquarters, September 2005

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International Harmonization
11th ICDRA recommended (2004, Spain)  Regulatory agencies should work together to make the best use of scientific resources related to herbal medicines.  Sharing national experience and information is crucial. WHO should facilitate these activities e.g. by providing updated monographs on medicinal plants and technical/regulatory guidance.

Technical Briefing Seminar, WHO Headquarters, September 2005

23

International Harmonization At Regional Level
FHH/WPRO
"Western Pacific Regional Forum for Harmonization of Herbal Medicine" (FHH) under support by WHO/WPRO


The Forum has seven founding member parties: Australia, China, Japan, The Republic of Korea, Singapore, Vietnam. Plus Hong Kong (SAR China)

Technical Briefing Seminar, WHO Headquarters, September 2005

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International Harmonization At Regional Level
The expected outcome of harmonization of FHH would be the development and commitment to common technical guidelines accepted by participating parties and based on discussions and consensus.
The specific purposes of harmonization include:  To provide a scientific basis for improvement or development of standards in safety, quality and efficacy of herbal medicines;  To reduce duplication of efforts;  To create economic use of valuable resources;  To address lack of standards in areas of public health importance to regulatory agencies.
Technical Briefing Seminar, WHO Headquarters, September 2005

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International Harmonization At Regional Level
NIS monographs /EURO: - NIS want monographs - NIS countries decided list: 16 from WHO existing monographs 14 new ones need to be developed SEARO - monographs for commonly used herbal medicine for primary health care (take place in June, DPR Korea).

Technical Briefing Seminar, WHO Headquarters, September 2005

26

Cooperation of Asian countries in the field of traditional medicine






ASEAN Consultative for Standards and Quality (ACCSQ) Product Working Group on Traditional Medicines and Health Supplement (TMHSPWG) The ACCSQ was formed by the ASEAN Economic Minister in 1992 with the aim of removing technical barriers to trades in order to facilitate the implementation of the Common Effective Preferential Tariff (CEPT) Agreement to realize the ASEAN Free Trade Area (AFTA) Objectives and Scope of TMHSPWG  Exchange, review and analyze information on the existing regulatory framework/regime including standard definition, terminologies, and technical infrastructure in Member Countries;  Study the existing regulatory frameworks/regime of selected countries and internationally accepted technical guidelines;  Enhance the technical infrastructure including mutual confidence in testing and conformity assessment.
Technical Briefing Seminar, WHO Headquarters, September 2005

27

International Harmonization for Regulation


Initiation of international harmonization in the field of regulation particularly for safety and quality control of herbal medicine products



An International Conference on harmonization in the field of regulation of herbal medicines will take place in November 2005, Canada - Why international harmonization is needed? - What kind of information and data need to share? - How to establish the mechanism of international harmonization?

Technical Briefing Seminar, WHO Headquarters, September 2005

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Conclusion
 Traditional Medicine will
contribute to human health care in the 21st century;

but…

 There are many challenges to
the safety and effective use of traditional medicine;

 The WHO Strategy will meet
the gaps and challenges;
It is long way to go...

Technical Briefing Seminar, WHO Headquarters, September 2005

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Thank you !
Traditional Medicine (TRM) Department of Technical Collaboration for Essential Drugs and Traditional Medicine World Health Organization, Geneva http://www.who.int/medicines

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