International Regulatory Cooperation on Proper Use of Traditional Medicine

1
International Regulatory Cooperation on Proper
Use of Traditional Medicine
Dr Xiaorui ZhangCoordinator Traditional
Medicine Department of Essential Drugs and
Traditional MedicineWorld Health Organization
2
Populations using TM/CAM worldwide
Germany
Sources Eisenberg DM et al. 1998 Fisher P
Ward A, 1994 Health Canada, 2001 World Health
Organization, 1998 and government reports
submitted to WHO.
3
Procedure for developing a new chemical drug
Duration at least 13 years Cost at least US
100 million
4
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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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

6
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

7
Number of Member States with Recently Established
Herbal Medicines Law or Regulation
65 of respondents have established herbal
medicines law or regulation
42 (49) declared regulations were in the process
of being developed.
Number of Countries before 1986 14 Number of
Countries Total 83
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Regulatory status of herbal medicines
Respondents were able to answer with more than
one option, if applicable, so the total number
exceeds number of respondents
9
Types of claims allowed for herbal medicines
Respondents were able to answer with more than
one option, if applicable, so the total number
exceeds number of respondents
10
Main Difficulties Regarding Regulatory Issues on
Traditional Medicines
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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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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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Working programme of ASIAN TMHS PWG
1. ASEAN consensus on specific area of
technical requirements for harmonization,
achieved
OBJECTIVE 1
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
STRATEGIES
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
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 resourcesand
• To address lack of standards in areas of public
  health importance to regulatory agencies.

17
Western Pacific Regional Forum for the
Harmonization of Herbal Medicines (FHH)

Secretariat (Provisional) Hong Kong
Standing Committee
Sub-committee II Quality Assurance
Information
Sub-committee I Nomenclature
Standardization
Nomenclature
EWG
Good Agricultural Practice
EWG
Information on General test
EWG
Good Manufacturing Practice
EWG
Validated Analytical Method
EWG
Adverse Drug Reaction, Sub-committee III
Testing method in Monograph
EWG
Chemical Reference Standards and Reference of
Medicinal Plant Materials
EWG
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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 (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
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Committee on Herbal
Medicinal Products
Austria France Lithuania Slovenia Estonia
Germany Luxembourg Spain Belgium Greece
Malta Sweden Cyprus 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
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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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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
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Member States' needs for WHO Support
127
116
117
117
110
105
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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/sub-regional/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
• 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

• 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