International Regulatory Cooperation on regulation of herbal medicines 29 March 2006, Brazil 1 Dr Xiaorui Zhang Coordinator Traditional Medicine Department.

International Regulatory Cooperation on regulation of herbal medicines 29 March 2006, Brazil

11

Dr Xiaorui ZhangDr Xiaorui ZhangCoordinatorCoordinator

Traditional MedicineTraditional MedicineDepartment of Essential Drugs and Traditional MedicineDepartment of Essential Drugs and Traditional Medicine

World Health OrganizationWorld Health Organization

International Regulatory Cooperation on International Regulatory Cooperation on Proper Use of Traditional MedicineProper Use of Traditional Medicine


22

Populations using TM/CAM worldwidePopulations using TM/CAM worldwide

Populations using traditional medicine for primary health care

60%

60%

70%

70%

70%

90%Ethiopia

Benin

India

Rwanda

Tanzania

Uganda

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

42%

48%

49%

70%

80%

Canada

Australia

France

USA

Sources: Eisenberg DM et al. 1998; Fisher P & Ward A, 1994; Health Canada, 2001;World Health Organization, 1998; and government reports submitted to WHO.

Germany


33

Duration: at least 13 yearsCost: at least US$ 100 million

Procedure for developing a new chemical drug


44

Reported by Prof Yeeng -chi Reported by Prof Yeeng -chi Cheng, Yale Medical School Cheng, Yale Medical School 20012001

The combination of The combination of 4 plants creates 4 plants creates powerful synergy powerful synergy for maximum for maximum anti-tumour effectanti-tumour effect

Difficulty for evaluation of herbal medicines

Removing any one of Removing any one of the 4 plants weakens the 4 plants weakens the effectiveness of the effectiveness of the formulathe formula


55

Major problems of international herbal markets

Quality problems Quality problems Quality inconsistence Use wrong species Labelling problem lack precautionsIncluding heavy metalsIncluding chemical substance or

illegal substance without announcement

Other problemsOther problemsLack registration information of

products in in the original countries Lack producer information in the

original countries Lack communication between

national drug authorities of imported and exported countries


66

WHO Global Survey and Database of National Policy and Regulation of TM/CAM

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


77

Number of Member States with Recently Established Herbal Medicines Law or Regulation

0

2

4

6

8

10

12

14

16

14 4 5 2 8 7 13 16 9 5

Before 1986

1986 - 1987

1988 - 1989

1990 - 1991

1992 - 1993

1994 - 1995

1996 - 1997

1998 - 1999

2000 - 2001

2002 - 2003

Number of Countries before 1986: 14

Number of Countries Total: 83

65% of respondents have

established herbal medicines law or regulation

42 (49%) declared regulations were in the process of being developed.


88

Regulatory status of herbal medicines

21

12

10

16

30

39

48

99

50

0 20 40 60 80 100 120

No Status

Other

Functional Food

Health Food

Herbal Medicines as a separateregulatory category

Self-medication only

Dietary Supplements

Over the Counter Medicines (O.T.C)

Prescription medicines

Number of Countries

Respondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents


99

Types of claims allowed for herbal medicines

5

7

50

62

91

40

0 20 40 60 80 100

No claims can be made according tothe law

Other claims

Structure/function claim

Nutrient content claims

Health claims

Medical claims

Number of CountriesRespondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents


1010

102

88

81

64

33

Lack of research data

Lack of appropriate controlmechanisms

Lack of education andtraining

Lack of expertise

Other

Main Difficulties Regarding Regulatory Issues on Traditional Medicines


1111

Why need to set up the TMHS-PWG

ASEAN consider the need to remove technical barriers of trade in order to facilitate the implementation of the Common Effective Preferential Tariff (CEPT) to realize the ASEAN Free Trade Agreement (AFTA) and to create a stable, prosperous and highly competitive ASEAN economic region.

To respond the new dynamics of the global challenges, ASEAN leaders have also approved to pursue accelerated integration of eleven priority sectors in 2010 which include Traditional Medicines and Health Supplement Products and formed a Product Working Group Traditional Medicines & Health Supplements Product Working Group (TMHS – PWG)

Traditional Medicines & Health Supplements Product Working Group (TMHS – PWG)


1212

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 framework/regime of selected countries and internationally accepted technical guidelines

Enhance the technical infrastructure including mutual confidence in testing and conformity assessment

Identify areas for possible harmonization and MRAs

Objectives

Traditional Medicines & Health Supplements Product Working Group (TMHS – PWG)


1313

1. ASEAN consensus on specific area of technical requirements for harmonization, achieved

OBJECTIVE 1

1.1.Exchange of information and analysis of the existing standard definition, terminologies, regulation & procedures amongst ASEAN Member Countries

1.3.Specified areas on the technical requirements for harmonization agreed upon among Member Countries

1.2. Comparative study on International and other regional technical requirements for TMHS, conducted

Template for exchange of information developed and agreed upon.

Technical requirements (including terminology and definition) of Member Countries compiled and analyzed

Profile of Technical requirements of Member Countries developed

Terminology and definition on TMHSstandardized in ASEAN

Technical Requirementsand guidelines of international and other regionalorganization compiled, compared and analyzed

Technical requirementsof selected other countries compiled, compared and analyzed

Appropriate model for ASEAN recommended

Specific Areas for Harmonization identified and agreed upon

STRATEGIES

EXPECTED OUTPUTS

Working programme of ASIAN TMHS – PWG


1414

Why need to set up the FHH Traditional Chinese medicine has been commonly used and traded with similar theory system among these countries. However, the quality standards and technical requirements in these countries vary. There is a need for cooperation in harmonization of standards for traditional Chinese medicines. Seven founding member parties: Seven founding member parties: 1. Australia1. Australia 2. China 2. China 3. Japan3. Japan 4. Republic of Korea 4. Republic of Korea 5. Singapore5. Singapore 6. Viet Nam 6. Viet Nam 7. Hong Kong (SAR China)7. Hong Kong (SAR China)

Western Pacific Regional Forum for the Harmonization of Herbal

Medicines (FHH)


1515

Nature of FHH

The FHH is a technical forum involving drug regulatory authorities of founding member parties to explore the way and measures for achieving the objectives set up by founding parties.

The role of the FHH is to provide technical documents and consensus on technical issues related to safety, efficacy and quality of herbal medicine.

Western Pacific Regional Forum for the Harmonization of Herbal

Medicines (FHH)


1616

Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH)

To provide a scientific basis for improvement or To provide a scientific basis for improvement or development of standards in safety, quality and development of standards in safety, quality and efficacy of herbal medicines;efficacy of herbal medicines;

To reduce duplication of efforts;To reduce duplication of efforts; To create economic use of valuable resources;andTo create economic use of valuable resources;and To address lack of standards in areas of public To address lack of standards in areas of public

health importance to regulatory agencies.health importance to regulatory agencies.


1717

Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH)

Standing Committee

Sub-committee IIQuality Assurance & Information

Sub-committee INomenclature & Standardization

Validated Analytical Method

Nomenclature

Chemical Reference Standards and Reference of Medicinal Plant Materials

Testing method in Monograph

Information on General testGood Manufacturing Practice

Good Agricultural Practice

Adverse Drug Reaction, Sub-committee III

Secretariat (Provisional)

Hong Kong

Secretariat (Provisional)

Hong Kong

EWG

EWG

EWG

EWG

EWG

EWG

EWG


1818

European Union

1. European Parliament (representation of the will of the EU citizens;

legislative power; control over community institutions)

2. European Commission (executive body)

3. Council of the EU (legislative body)

Agencies of the MS and of the European Union (EMEA)Specific Committee on Herbal Medicinal Products


1919

Committee on Herbal Committee on Herbal Medicinal Products Medicinal Products

Austria France Lithuania SloveniaEstonia Germany Luxembourg SpainBelgium Greece Malta SwedenCyprus Hungary Netherlands United Kingdom Czech Rep. Ireland Poland Denmark Italy Portugal Finland Latvia Slovak Republic

EEA Members:Norway, Iceland

Observer: EDQM/Europ. Pharm.

Romania; Bulgaria


2020

EU Council: a European approach to non-conventional medicine resolution 1026, 1999

EU Commission: the Directive 2001/83/EC as regards traditional medicinal products, amended by 2004

EMEA: the evidence of safety and efficacy required for well-established herbal medicinal products in bibliographic application 1999

EMEA: the implementation of different levels of scientific evidence in core-data for herbal drugs 2003

Legal and technical requirements for herbal medicines


2121

Marketing Authorisation of Herbal Medicinal Products in the EU

National Authorisation

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

basis for:

Mutual Recognition of marketing authorizationsDecentralized marketing authorizations


2222

Member States' needs for WHO Support

67

66

50

16

44

48

47

50

44

55

8

4

7

5

3

9

12

0

68

83

70

0 20 40 60 80 100 120 140

Information-sharing on regulatory issues

Herbal medicine safety monitoring workshops

General guidelines on research and evaluation ofherbal medicines

Provision of databases

Herbal medicine regulation workshops

Global meetings

Other

Number of Member States

Much needed

Needed

Not needed

127

116

117

117

110

105


2323

WHO Working group meeting on international WHO Working group meeting on international regulatory cooperation on herbal medicinesregulatory cooperation on herbal medicines

WHO Working group meeting on regulatory cooperation on WHO Working group meeting on regulatory cooperation on herbal medicinesherbal medicines in Ottawa, Canada from 28 to 30 November in Ottawa, Canada from 28 to 30 November 2005 hosted by the Health Products and Food Branch of Health 2005 hosted by the Health Products and Food Branch of Health Canada. Canada.

29 regulatory authorities from 16 countries participated, 29 regulatory authorities from 16 countries participated, regulatory authorities representing each of the 6 regional/sub-regulatory authorities representing each of the 6 regional/sub-

regional/inter-regional regulatory cooperation groups including regional/inter-regional regulatory cooperation groups including Forum on Harmonization of Herbal Medicines (FHH), the Pan Forum on Harmonization of Herbal Medicines (FHH), the Pan American National Drug Regulatory Authorities American National Drug Regulatory Authorities Harmonization (PANDRH), the European Herbal Medicines Harmonization (PANDRH), the European Herbal Medicines Committee, the ASEAN Product Working Group on Committee, the ASEAN Product Working Group on Traditional Medicines and Health Supplements (TMHSPWG) Traditional Medicines and Health Supplements (TMHSPWG) and the Latin American Parliament (PARLATINO)and the Latin American Parliament (PARLATINO)


2424

International regulatory Cooperation on Herbal Medicines (IRCH)

Objectives globally promote and facilitate the globally promote and facilitate the safe use of herbal medicines, safe use of herbal medicines,

including through regional initiatives, through sharing information including through regional initiatives, through sharing information and fostering dialogue;and fostering dialogue;

facilitate and strengthen cooperation between national drug facilitate and strengthen cooperation between national drug regulatory authorities by sharing experience and information related regulatory authorities by sharing experience and information related to the regulation, safety and quality of herbal medicines; to the regulation, safety and quality of herbal medicines;

further discuss existing requirements and standards to promote the further discuss existing requirements and standards to promote the regulation, safety and quality of herbal medicines;regulation, safety and quality of herbal medicines;

further share research and knowledge of traditional medicines to further share research and knowledge of traditional medicines to reduce duplication;reduce duplication;

recommend future activities to WHO related to the safe use of herbal recommend future activities to WHO related to the safe use of herbal medicines;medicines;

recommend important issues to ICDRA for further discussion related recommend important issues to ICDRA for further discussion related to the safe use herbal medicines.to the safe use herbal medicines.


2525

International regulatory Cooperation International regulatory Cooperation on Herbal Medicines (IRCH)on Herbal Medicines (IRCH)

Initial scope of activities of IRCHIRCH is in the initial stages. There are two main IRCH is in the initial stages. There are two main

activities:activities: Information sharing on technical matters Information sharing on technical matters

related to regulatory information of herbal related to regulatory information of herbal medicines via electronic communication as the medicines via electronic communication as the main tool, on a daily basis, through an main tool, on a daily basis, through an Information Focal Point nominated by each Information Focal Point nominated by each Member Country of IRCH.Member Country of IRCH.

Convening annual meetings of IRCH.Convening annual meetings of IRCH.

Second working group meeting will take place in Second working group meeting will take place in October 2006, Beijing, ChinaOctober 2006, Beijing, China


2626

Conclusion Conclusion

Status and regulation of herbal medicines vary between Status and regulation of herbal medicines vary between country to countrycountry to country

The most difficulties for national authorities are the The most difficulties for national authorities are the lack lack of research data, the lack of appropriate control of research data, the lack of appropriate control mechanisms, the lack of education and training of mechanisms, the lack of education and training of providers and the lack of expertise. providers and the lack of expertise.

Information exchange and sharing national experience is Information exchange and sharing national experience is crucial aspect crucial aspect

WHO will provide support to the international and WHO will provide support to the international and regional regulatory cooperation for herbal medicines regional regulatory cooperation for herbal medicines

International Regulatory Cooperation on regulation of herbal medicines 29 March 2006, Brazil 1 Dr Xiaorui Zhang Coordinator Traditional Medicine Department.

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