Transcript Antimicrobial resistance

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International Regulatory Cooperation on
Proper Use of Traditional Medicine
Dr Xiaorui Zhang
Coordinator
Traditional Medicine
Department of Essential Drugs and Traditional Medicine
World Health Organization
International Regulatory Cooperation on regulation
of herbal medicines 29 March 2006, Brazil
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Populations using TM/CAM worldwide
Ethiopia
Populations using
traditional medicine
for primary health
care
Populations in
developed countries
who have used
complementary and
alternative medicine at
least once
90%
Benin
70%
India
70%
Rwanda
70%
Tanzania
60%
Uganda
60%
Germany
80%
Canada
70%
France
49%
Australia
48%
USA
42%
Sources: Eisenberg DM et al. 1998; Fisher P & Ward A, 1994; Health Canada, 2001;
World Health Organization, 1998; and government reports submitted to WHO.
International Regulatory Cooperation on regulation
of herbal medicines 29 March 2006, Brazil
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Procedure for developing a new
chemical drug
Duration: at least 13 years
Cost: at least US$ 100 million
International Regulatory Cooperation on regulation
of herbal medicines 29 March 2006, Brazil
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Difficulty for evaluation of herbal medicines
The combination of
4 plants creates
powerful synergy
for maximum
anti-tumour effect
Removing any one of
the 4 plants weakens
the effectiveness of the
formula
Reported by Prof Yeeng -chi
Cheng, Yale Medical School
2001
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of herbal medicines 29 March 2006, Brazil
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Major problems of international
herbal markets
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Quality problems
Quality inconsistence
Use wrong species
Labelling problem
lack precautions
Including heavy metals
Including chemical substance or
illegal substance without
announcement
Other problems
Lack 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
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of herbal medicines 29 March 2006, Brazil
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WHO Global Survey and Database of
National Policy and Regulation of TM/CAM
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International Regulatory Cooperation on regulation
of herbal medicines 29 March 2006, Brazil
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
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Number of Member States with Recently Established
Herbal Medicines Law or Regulation
16
65% of
respondents have
established
herbal medicines
law or regulation
14
12
10
8
6
42 (49%) declared
regulations were
in the process of
being developed.
4
2
0
Before 1986 - 1988 - 1990 - 1992 - 1994 - 1996 - 1998 - 2000 - 2002 1986
1987
1989
1991
1993
1995
1997
1999
2001
2003
14
4
5
2
8
7
Number of Countries before 1986: 14
Number of Countries Total:
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of herbal medicines 29 March 2006, Brazil
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13
16
9
5
8
Regulatory status of herbal medicines
Prescription medicines
50
Over the Counter Medicines (O.T.C)
99
Dietary Supplements
48
Self-medication only
Herbal Medicines as a separate
regulatory category
Health Food
39
30
16
Functional Food
10
Other
12
No Status
21
0
20
40
60
80
100
Number of Countries
Respondents were able to answer with more than one option,
if applicable, so the total number exceeds number of
respondents
International Regulatory Cooperation on regulation
of herbal medicines 29 March 2006, Brazil
120
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Types of claims allowed for herbal medicines
Medical claims
91
Health claims
62
Nutrient content claims
50
Structure/function claim
40
Other claims
7
No claims can be made according to
the law
5
0
Respondents were able to answer with
more than one option, if applicable, so the
total number exceeds number of
respondents
International Regulatory Cooperation on regulation
of herbal medicines 29 March 2006, Brazil
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40
60
80
Number of Countries
100
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Main Difficulties Regarding Regulatory
Issues on Traditional Medicines
102
Lack of research data
Lack of appropriate control
mechanisms
88
Lack of education and
training
81
64
Lack of expertise
Other
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Traditional Medicines & Health Supplements Product
Working Group (TMHS – PWG)
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)
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of herbal medicines 29 March 2006, Brazil
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Traditional Medicines & Health Supplements
Product Working Group (TMHS – PWG)
Objectives
 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
International Regulatory Cooperation on regulation
of herbal medicines 29 March 2006, Brazil
Working programme of ASIAN TMHS – PWG
1. ASEAN consensus on specific area of technical requirements for
harmonization, achieved
OBJECTIVE 1
STRATEGIES
1.2.
Comparative study
on International
and other regional
technical
requirements for
TMHS, conducted
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
EXPECTED
OUTPUTS
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
International Regulatory Cooperation on regulation
of herbal medicines 29 March 2006, Brazil
Terminology
and
definition
on TMHS
standardized
in ASEAN
Technical
Requirements
and guidelines
of international
and other
regional
organization
compiled,
compared and
analyzed
Technical
requirements
of selected
other
countries
compiled,
compared
and analyzed
Appropriate
model for
ASEAN
recommended
Specific Areas
for
Harmonization
identified
and agreed upon
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Western Pacific Regional Forum for
the Harmonization of Herbal
Medicines (FHH)
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:
1. Australia
2. China
3. Japan
4. Republic of Korea
5. Singapore
6. Viet Nam
7. Hong Kong (SAR China)
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Western Pacific Regional Forum for
the Harmonization of Herbal
Medicines (FHH)
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.
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Western Pacific Regional Forum for the
Harmonization of Herbal Medicines (FHH)
 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;and
 To address lack of standards in areas of public
health importance to regulatory agencies.
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Western Pacific Regional Forum for the
Harmonization of Herbal Medicines (FHH)
Standing Committee
Secretariat
(Provisional)
Hong Kong
Sub-committee I
Nomenclature & Standardization
Sub-committee II
Quality Assurance &
Information
Nomenclature EWG
Information on General testEWG
Validated Analytical MethodEWG
Testing method in Monograph
EWG
Good Agricultural Practice EWG
Good Manufacturing Practice
EWG
Adverse Drug Reaction, Subcommittee III
EWG
Chemical Reference Standards and Reference of Medicinal Plant Materials
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European Union
1. European Parliament
(representation of the will of the EU citizens; legislative
power; control over community institutions)
2. European Commission
3. Council of the EU
(executive body)
(legislative body)
Agencies of the MS and of the European Union (EMEA)
Specific Committee on Herbal Medicinal Products
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Committee on Herbal
Medicinal Products
Austria
Estonia
Belgium
Cyprus
Kingdom
Czech Rep.
Denmark
Finland
France
Germany
Greece
Hungary
Lithuania
Luxembourg
Malta
Netherlands
Ireland
Italy
Latvia
Poland
Portugal
Slovak Republic
EEA Members:
Norway, Iceland
Observer:
Pharm.
Slovenia
Spain
Sweden
United
EDQM/Europ.
Romania; Bulgaria
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of herbal medicines 29 March 2006, Brazil
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Legal and technical requirements
for herbal medicines

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
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of herbal medicines 29 March 2006, Brazil
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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 authorizations
Decentralized marketing authorizations
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of herbal medicines 29 March 2006, Brazil
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Member States' needs for WHO Support
83
Information-sharing on regulatory issues
68
Herbal medicine safety monitoring workshops
General guidelines on research and evaluation of
herbal medicines
67
Herbal medicine regulation workshops
66
Global meetings
Not needed
47
50
44
50
Other
16
0
55
12
127
7
116
5
117
3
9
117
110
105
80
20
40
60
80
100 120 140
Number of Member States
International Regulatory Cooperation on regulation
of herbal medicines 29 March 2006, Brazil
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48
70
Provision of databases
Much needed
Needed
44
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WHO Working group meeting on international
regulatory cooperation on herbal medicines
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WHO Working group meeting on regulatory cooperation on
herbal medicines in Ottawa, Canada from 28 to 30 November
2005 hosted by the Health Products and Food Branch of Health
Canada.
29 regulatory authorities from 16 countries participated,
regulatory authorities representing each of the 6 regional/subregional/inter-regional regulatory cooperation groups including
Forum on Harmonization of Herbal Medicines (FHH), the Pan
American National Drug Regulatory Authorities Harmonization
(PANDRH), the European Herbal Medicines Committee, the
ASEAN Product Working Group on Traditional Medicines and
Health Supplements (TMHSPWG) and the Latin American
Parliament (PARLATINO)
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International regulatory Cooperation on Herbal
Medicines (IRCH)
Objectives
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globally promote and facilitate the safe use of herbal medicines,
including through regional initiatives, through sharing information
and fostering dialogue;
facilitate and strengthen cooperation between national drug
regulatory authorities by sharing experience and information related
to the regulation, safety and quality of herbal medicines;
further discuss existing requirements and standards to promote the
regulation, safety and quality of herbal medicines;
further share research and knowledge of traditional medicines to
reduce duplication;
recommend future activities to WHO related to the safe use of herbal
medicines;
recommend important issues to ICDRA for further discussion related
to the safe use herbal medicines.
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International regulatory Cooperation
on Herbal Medicines (IRCH)
Initial scope of activities of IRCH
IRCH is in the initial stages. There are two main
activities:
 Information sharing on technical matters
related to regulatory information of herbal
medicines via electronic communication as the
main tool, on a daily basis, through an
Information Focal Point nominated by each
Member Country of IRCH.
 Convening annual meetings of IRCH.
Second working group meeting will take place in
October 2006, Beijing, China
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Conclusion
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Status and regulation of herbal medicines vary between
country to country
The most difficulties for national authorities are the lack
of research data, the lack of appropriate control
mechanisms, the lack of education and training of
providers and the lack of expertise.
Information exchange and sharing national experience is
crucial aspect
WHO will provide support to the international and
regional regulatory cooperation for herbal medicines
International Regulatory Cooperation on regulation
of herbal medicines 29 March 2006, Brazil