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Organizational structure

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1. Nature of FHH

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 FHH is to provide technical documents and consensus on technical issues related to safety, efficacy
and quality of herbal medicine. It was considered these documents and consensus views will provide a reference for
consideration and action by drug regulatory authorities where appropriate.
For FHH, inherent in the concept of harmonization is the notion of diversity and differences and of working towards
one common framework, which is acceptable to all participating parties.
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 the lack of standards in areas of public health importance to regulatory agencies.

The expected outcome of harmonization would be the development and commitment to common technical
guidelines, which are acceptable to participating parties and based on discussions and consensus.

2. Objective of FHH

The general proposed objective of FHH is to promote public health by recognizing and developing standards and
technical guidelines that aim to improve the quality, safety and efficacy of herbal medicines.

3. Membership of FHH

Membership of FHH shall consist of representatives from relevant regulatory authorities, related research and
academic institutions, and invited relevant industry associations from party members.

4. Organizational structure

FHH Standing Committee is the responsible group for all activities related to FHH.

5. Working principles of the FHH

5-1 The basic principles of FHH are:
  • i. Equal partnership of seven founding members;
  • ii. Trust is an important guiding principle;
  • iii. An evidence-based approach should be applied;
  • iv. Through collegial, open and frank discussion, achieve mutual understanding, minimize differences and maximize common
    ground. It is important to set aside tasks that are difficult to resolve and to focus on tasks that are most likely to achieve consensus
    (simpler tasks);
  • v. In case there is a difficult issue with divergent views, we suggest to follow the guidance of WHO traditional medicine.
  • i.e. consultation, discussion, consensus building.
5.2 Criteria for setting priorities (criteria to select and tackle issues)

Issues related to herbal medicines are complex and numerous. FHH should commence focus on issues:

  • i. Where some initial scientific work has already been commenced, or where the relevant technology has been developed;
  • ii. That are of regional and international concern (more than of concern to only one member party);
  • iii. That are critical for overall improvement in safety, quality and efficacy of herbal medicines,
  • e.g. starting materials, GAP, Processing of raw herbs, etc. official compendium, nomenclature, any work that supports quality of herbal medicines

6. Sub-Committees

6.1 Terms of reference of Sub-Committee
  • To perform tasks assigned by the Standing Committee in relation to their focus area of activity;
  • To develop their respective plans of activity;
  • To draft technical documents in the assigned areas and submit those documents for approval by the Standing Committee;
  • To organize expert working groups to support the Sub-Committee activities
6.2 Convenor of Sub-Committee

A member party will be appointed by the Standing Committee as a convenor member for each Sub-Committee.

The convenor member party will coordinate the work of the Sub-Committee and act as the bridge between
the Sub-Committee and Standing Committee. The convenor of the Sub-Committee should serve for two years.
The convenor should copy communications with member parties and experts/institutions involved in works of
Sub-Committees to the secretariat for filing and necessary actions.

The convenor member party will be responsible for funding the secretariat support and meeting venue for the
Sub-Committee and expert working groups.

6.3 The chair of the Sub-Committee

The convenor member is responsible to appoint an individual as the chairperson of Sub-Committee

The chair of the Sub-Committee will be appointed by and responsible to report to the Standing Committee.
Sub-Committees (and expert working groups) should report to each Standing Committee meeting.
Meetings locations can be decided by the member party acting as a convenor for the respective Sub-Committee.
The coordinating member party is to support the Sub-Committees by providing access to the secretariat for
the Sub-Committee meetings.

The Sub-Committees are to report to the Standing Committee with proposals before any public action on their
activities (e.g. provision of the website, publicizing regional guidelines).
Reports of Sub-Committees will be transmitted to the secretariat of the Standing Committee for filing and necessary action.

6.4 Membership of Sub-Committees

Members of Sub-Committees appointed by the convenor member party, can be drawn from founding members.
No fixed members, but the emphasis is on including appropriate expertise. A list of relevant experts can be provided
by the member parties as potential candidates to serve on the Sub-Committees or expert working groups.
Members of the Sub-Committees can be voluntary appointment

7. Expert working groups

7.1 Term of reference of the expert working group
7.2 Members of the expert working group

The convenor member of Sub-Committee has the authority to set up the expert working group(s) in special areas
identified by Sub-Committees. Expert working groups can operate flexibly (1 or more persons, no need to involve
all member states) to produce the technical documents. The members of the expert working group will be selected
by the convenor member from amongst experts within founding parties or experts from other countries.

8. FHH Conferences

The Standing Committee will organize conferences of FHH dependent on FHH outcomes.
The conference will be open to all interested parties and act as a venue for dissemination of information on projects of FHH.

9. Funding

Funding to support the function and activities of FHH will be sought from interested member parties, industry
associations and other organizations. Representatives of member parties will fund their own travel, accommodation
and related expenses to attend meetings. The coordinating member will be responsible for funding the secretariat
support to the Standing Committee. Funding for Sub-Committees and expert working groups is to be provided by
the convening member party.