Transcript Antimicrobial resistance - WHO archives

1
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
Briefing on TBS Training course 18 Sep 2006 Geneva
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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.
Briefing on TBS Training course 18 Sep 2006 Geneva
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Germany & France dominate on
European herbals market
Total Market 09/2003-09/2004: ~ 3.7 billion € ex-factory
2%
2%
2%
GERMANY
11%
FRANCE
39%
4%
ITALY
POLAND
UK
5%
SPAIN
6%
SWITZERLAND
BELGIUM
8%
21%
NETHERLANDS
OTHERS
Briefing on TBS Training course 18 Sep 2006 Geneva
Source: IMS 2005
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Herbal Market in China (2004)
Annual Sales Comparison between Traditional
Chinese Medicines and Western Medicine
TCMs (Preparations &
Processed Products)
- RMB 84.9 billion (USD 10.3
billion)
37%
63%
Western Medicines
- RMB 144.6 billion (USD
17.6 billion)
Briefing on TBS Training course 18 Sep 2006 Geneva
TCM
Western Medicines
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Projected Worldwide Growth of Herbal
Remedies Until 2006
25.0
+ 2.4%/a
20.0
+ 8.5%/a
15.0
10.0
5.0
0.0
2000
2001
2002
Sports/Specialty
Briefing on TBS Training course 18 Sep 2006 Geneva
2003
2004
Herbals
2005
VMS
2006
Sources: Phytopharm Consulting, Datamonitor
30.0
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Traditional medicine contribute to health
Artemisinin is a new anti-malarial drug. It
was discovered from Artemisia annua L.
which is traditionally used Chinese medicine
for treatment of malaria and other health
problems. WHO recommends to use
Artemisinin based combined therapy (ACT)
for the treatment of falciparum malaria since
2002
Currently, Tamiflu is the only drug for avian
influenza. It is based on shikimic acid which
is abstracted from plant Illicium
lanceolalum, which is also one of
traditionally used Chinese medicines
Briefing on TBS Training course 18 Sep 2006 Geneva
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Difficulties Specific to TM/CAM Research
Characteristics of Western Medicine
The main philosophy of Western
Medicine is that if the human body is
struck by diseases, the causative agent
must be identified and dealt with in
order to return patients to a state of
good health.
Briefing on TBS Training course 18 Sep 2006 Geneva
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Difficulties Specific to TM/CAM Research
A common feature of most systems of Traditional
Medicine is that they take a 'holistic' approach
towards the sick individual and treat disturbances
on the physical, emotional, mental and living
environment levels simultaneously.
Briefing on TBS Training course 18 Sep 2006 Geneva
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Procedure for developing a new
chemical drug
Duration: at least 13 years
Cost: at least US$ 100 million
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Evaluation of Efficacy of Herbal Medicines
The combination of
4 plants creates
powerful synergy
for maximum
anti-tumour effect
10
Removing any one of
the 4 plants weakens
the effectiveness of the
formula
Reported by Prof Yeeng -chi Cheng,
Yale Medical School 2001
Briefing on TBS Training course 18 Sep 2006 Geneva
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WHO Traditional Medicine Strategy
2002-2005
1
Policy:
2
Safety, efficacy and quality:
3
Access:
4
Rational use:
Briefing on TBS Training course 18 Sep 2006 Geneva
integrate TM/CAM
with national health care systems
provide evaluation, guidance and
support for effective regulation
ensure availability and
affordability of TM/CAM, including
essential herbal medicines
promote
therapeutically-sound use of TM/CAM
by providers and consumers
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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
Briefing on TBS Training course 18 Sep 2006 Geneva
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WHO Global Survey and database of
traditional medicine
Objectives
 To collect updated and comprehensive information on


TM/CAM policies and regulations of herbal medicines to
make analysis on the current situation and major challenges
To clarify what are specific needs on capacity building
regarding TM/CAM and regulations of herbal medicines and
what directed support WHO should provide to the Member
States accordingly. r To update the document “Regulatory
Situation of Herbal Medicines- a world wide review”.
To monitor the impact of the WHO Strategy for Traditional
Medicine in relation to present national policy and
regulation on TM/CAM/herbal medicines.
Briefing on TBS Training course 18 Sep 2006 Geneva
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Challenges of definition of herbal medicines
Definition
Finished herbal products
Finished herbal products consist of herbal preparations made from
one or more herbs. If more than one herb is used, the term mixture
herbal product can also be used. Finished herbal products and
mixture herbal products may contain excipients in addition to the
active ingredients. However, finished products or mixture products
to which chemically defined active substances have been added,
including synthetic compounds and/or isolated constituents from
herbal materials, are not considered to be herbal.
Recommendation from workshop of herbal medicines, 11th ICDRA, 2002
Member States should strengthen the post-marketing surveillance
system of herbal medicines. Particular attention should be given to
the possible adulteration of herbal medicines by chemicals or other
ingredients which have not been labelled.
Briefing on TBS Training course 18 Sep 2006 Geneva
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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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83
13
16
9
5
16
Types of herbal medicines regulation
The law or
regulation for
herbal medicines
is partly the
43
Separate law or
regulation for
herbal medicines
22
Same law or
regulation as for
conventional
pharmaceuticals
46
0
10
20
30
40
Number of Countries
Respondents were able to answer with more than one option, if applicable, so
the total number exceeds number of respondents
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17
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
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120
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Challenges of regulatory status of herbal
medicines
 e.,g Garlic
 If Garlic intends to be used as food spice, it is food, but if it



is used to stop diarrhoea, it is herbal medicines
Garlic gel is categorised a herbal medicine product in
Germany
Garlic gel is categorised a food supplement in UK and USA
Garlic gel is categorised a health food in Japan
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Challenges of regulatory status of herbal
medicines
 It is difficult to distinguish between herbal medicines




and health food or diet-supplement
Definition depend on countries own used experience
Definition highly depend on labeling and intended use
(claims)
Highly depend national regulation of food and
medicines
Clinical or bibliographic data on efficacy could refer to
regulate products into diet-supplement or medicine
categories
Briefing on TBS Training course 18 Sep 2006 Geneva
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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
Briefing on TBS Training course 18 Sep 2006 Geneva
20
40
60
80
Number of Countries
100
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What is "evidence" in the field of medicine?
Randomized selection, Double-blinded, Placebo-controlled trials.
A
A. Randomized Controlled Trials
(RCT)
B
B. Well-conducted Clinical
Studies
14%
C. Expert Committee Reviews
or the clinical experience of
respected authors.
28%
C
8%
“Using Clinical Guidelines to Improve Patient Care within the NHS "1996
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Level of evidence requirement (Australia)
Level of
claim
Type of claim
Evidence required of support claim
HIGH
Treats/cures/manages any disease/disorder.
Prevention of any disease or disorder.
Treatment of vitamin or mineral deficiency
diseases.
High level. Registration only –
evaluated by the CMEC, MEC
(Medicines Evaluation Committee) or
the ADEC (Australian Drug
Evaluation Committee).
MEDIUM
Health enhancement2.
Reduction of risk of a disease/disorder.
Reduction in frequency of a discrete event.
Aids/assists in the management of a named
symptom/disease/disorder.Relief of symptoms of
a named disease or disorder3.
Medium level. Sponsor must hold the
evidence for Listable goods.
GENERAL
Health maintenance, including nutritional
support.Vitamin or mineral supplementation4.
Relief of symptoms (not related to a disease or
disorder)3.
General level. Sponsor must hold the
evidence for Listable goods.
Briefing on TBS Training course 18 Sep 2006 Geneva
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Level of evidence required for the
regulation of TM/CAM
Two types of evidence which can be used to support
claims (EU)
 scientific evidence
 evidence based on traditional use of products, which
have been on the market for at least 30 years
without any risks reported. (15 years within
European countries and 15 outside European
countries)
Briefing on TBS Training course 18 Sep 2006 Geneva
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Number of Registered Herbal Medicines
18
16
14
12
Number of 10
Countries 8
6
4
2
0
1-50
51-100
101200
201300
301500
5001000
1000
and
18
8
9
5
4
4
18
Number of Herbal Medicines Registered
Number of Countries Total: 66
Briefing on TBS Training course 18 Sep 2006 Geneva
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Number of Member States with Regulatory
Requirements for Good Manufacturing
Practice
Same rules of good
manufacturing practice
Adherence to
information in
73
59
30
Special GMP rules
28
No requirements
15
Question not answered
6
Other Namely
0
20
40
60
80
Number of Member States
Briefing on TBS Training course 18 Sep 2006 Geneva
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Major problems of international
herbal markets


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
Briefing on TBS Training course 18 Sep 2006 Geneva
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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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28
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
Briefing on TBS Training course 18 Sep 2006 Geneva
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48
70
Provision of databases
Much needed
Needed
44
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ASEAN Regulatory Cooperation for Herbal Medicine
ASEAN Consultative Committee for Standards And
Quality (TMHS- PWG, ACCSQ)

TMHS-PWG formed in August 2004 to implement measures on
TM & HS under Healthcare integration roadmap



Chaired by Indonesia
Co-chaired by Malaysia
Member countries (10 countries)
Brunei Darussalam,
Cambodia,
Lao,
Malaysia,
Philippines,
Singapore,
Vietnam
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Indonesia,
Myanmar,
Thailand,
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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)
Briefing on TBS Training course 18 Sep 2006 Geneva
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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
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ASEAN Regulatory Cooperation for Herbal Medicine
 TMHS-PWG meets 2 x/year and to date 3 meeting
had been conducted
 Certain member countries is assigned to further
review, study and analyzes technical requirement
on specific areas which will then be discussed during
the meeting and or distributed between the meeting
to member countries for further comments
Briefing on TBS Training course 18 Sep 2006 Geneva
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
Terminology
and
definition
on TMHS
standardized
in ASEAN
Briefing on TBS Training course 18 Sep 2006 Geneva
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)
Briefing on TBS Training course 18 Sep 2006 Geneva
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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.
Briefing on TBS Training course 18 Sep 2006 Geneva
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36
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.
Briefing on TBS Training course 18 Sep 2006 Geneva
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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
Briefing on TBS Training course 18 Sep 2006 Geneva
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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
Briefing on TBS Training course 18 Sep 2006 Geneva
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Herbal Medicinal Products in the EU Access
to the market
Marketing Authorization
1. Full documentation with new tests and trials
mandatory for:
- any herbal medicinal product never marketed in the
EU
- therapeutic innovations
- new indication / therapeutic area for “old” products
2. Full bibliographic documentation
Registration (well-established use)
3. Simplified dossier for traditional products
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The new simplified registration procedure
Registration of traditional herbal medicinal products
applicable to traditional herbal medicinal products
Article 16c 1 (c)
> 30 years of medicinal use within the EU or
> 15 years in and > 15 years outside the EU
Deviations may be decided by the Herbal Committee if
requested by a Member State
Briefing on TBS Training course 18 Sep 2006 Geneva
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 Third PARLATINO Inter-parliamentary Health
Conference was held in Sao Paulo in 2005 and
attended by 74 parliamentarians from 17 countries.
 The “Parliamentary Group on Traditional and
Complementary Medicine” was created with the
purpose of monitoring the question of legislative
norms on TCM in Latin America.
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Project
 Drawing up a draft framework law on traditional
and complementary medicine for approval by
PARLATINO (first stage).
 Preparation of ad hoc legislation on traditional
and complementary medicine based on the
framework law adopted by PARLATINO, for
discussion and approval by the national congresses
and legislative assemblies of the countries of Latin
America (second stage).
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PAHO/WHO and PANDRH
to act as directing and coordinating authority on
international health work; and to develop, establish and
promote international standards with respect to biological,
pharmaceutical and similar products;
WHO Mandate:
PAN American Sanitary Conference supports the development of essential
drug policies that include drug legislation and registration; drug
manufacturing and marketing; and drug use and drug financing; that
promotes the establishment of pharmaceutical services and drug
information for health workers and public education promoting the
rational use of medicines
42nd PAHO/WHO Directing Council: September 2000
Resolution supporting PANDRH
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PANDRH Structure and Operating System
Regulators
Andean Area
CARICOM
MERCOSUR
SICA
NAFTA
INDUSTRY
Pan American
Conference
Secretariat
Steering Committee
Consumers
Academia
Professional Ass
WG
WG WG
WG
WG WG
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Organization of PADRH
NRA
Members
NA:
Mexico
CA*:
Costa Rica
CR*:
Trinidad &Tobago
ME*:
Argentina
AA:
Colombia
Pharmaceutical Industry
One rep from FIFARMA
One rep from ALIFAR
Briefing on TBS Training course 18 Sep 2006 Geneva
Alternate
USA
Panama
Barbados
Chile
Bolivia
-------------------------
48
Mission of ANDRAH Working Group
of Herbal Medicines

To foster a common understanding of MP in
the Region of the Americas and to develop
recommendations to promote regulatory
harmonization taking into consideration the
traditional and sustainable use of Medicinal
Plants.
Briefing on TBS Training course 18 Sep 2006 Geneva
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Objectives of ANDRAH Working
Group of Herbal Medicines




To promote and strengthen the exchange of information
about MP
To promote the assurance of quality, safety and efficacy of
MP in the Americas, including the development of programs
for vigilance and control;
To develop proposals for harmonized regulatory activities in
the area of MP; and to support countries in the
implementation of these activities once they have been
adopted by PANDRH;
To promote activities and educational programs on MP for
health care providers, consumers, and the public in general.
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WHO Working group meeting on international
regulatory cooperation on herbal medicines



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)
Briefing on TBS Training course 18 Sep 2006 Geneva
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International regulatory Cooperation on Herbal
Medicines (IRCH)
Objectives






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.
Briefing on TBS Training course 18 Sep 2006 Geneva
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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




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
Briefing on TBS Training course 18 Sep 2006 Geneva
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Thanks
for all of your support and
cooperation in the past and
looking forward in the future
Traditional Medicine
Department of Technical Cooperation for
Essential Drugs and Traditional Medicine
Websites: http://www.who.int/medicines/areas/traditional/en/index.html
http//www.who.int
E-mail: [email protected]
Briefing on TBS Training course 18 Sep 2006 Geneva