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. It was
considered these documents and consensus views will provide
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:
provide a scientific basis for improvement or development
of standards in safety, quality
- and efficacy of herbal medicines;
reduce duplication of efforts;
create economic use of valuable resources; and
address 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
The general proposed objective of the 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.
Membership of FHH shall consist of representatives from
relevant regulatory authorities, related research and academic
institutions, and invited relevant industry associations
from party members.
The FHH Standing Committee is the responsible group for
all activities related to the FHH.
Figure1. Organizational Structure of the FHH
---5.1 The basic principles
of the FHH are:
Equal partnership of 7 founding members;
Trust is an important guiding principle;
An evidence-based approach should be applied
Through collegial, open and frank discussion, achieve mutual
differences and maximize common ground. It is important
to set aside tasks that are difficult
to resolve and focus on tasks that are most likely to
achieve consensus(simpler tasks).
In case there is a difficult issue with divergent views,
we suggest to follow the WHO trad
consultation, discussion, consensus building.
---5.2 Criteria for setting
priorities(criteria to select and tackle issues)
-----ssues related to
herbal medicines are complex and numerous. The FHH should
-----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
-----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,
work that supports quality of
---6.1 Terms of reference of
perform tasks assigned by the Standing Committee in relation
to their focus area of activity.
develop their respective plans of activity.
draft technical documents in the assigned areas and submit
those documents for approval ------
by the Standing Committee.
organize expert working groups to support the sub-committee
Convenor of sub-committee
-----A member party will
be appointed by the Standing committee as convenor member
-----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
-----should serve for
two years. The convenor should copy communications with
involved in works of sub-committees to the secretariat for
-----and neccssary actions.
-----The convenor member
party will be responsible for funding the secretariat support
-----meeting venue for
the Sub-committee and expert working groups.
The chair of the sub-committee
convenor member is responsible to appoint an individual
as the chairperson of
-----The chair of the
sub-committee will be appointed by and responsible to report
to the Standing
expert working groups) should report to each Standing
Meetings locations can be decided by the member party acting
-----for the respective
sub-committee. The co-ordinating member party is to support
providing access to the secretariat for the sub-committee
are to report to the Standing Committee with proposals before
-----public action on
their activities(eg provision of website,publicising regional
-----Reports of sub-committees
will be transmitted to the secretariat of Standing Committee
-----filing and necessary
Membership of Sub-committees
of Sub-committees appointed by convenor member party, can
be drawn from founding
-----members. No fixed
members, but emphasis is on including appropriate expertise.
A list of
can be provided by the member parties as potential candidates
to serve on the
expert working groups. Members of the sub-committees can
Term of reference of expert working group
Members of expert working group
-----The convenor member
of sub-committee has the authority set up expert working
-----special areas identified
by sub-committees. The expert working groups can operate
-----(1 or more persons,
no need to involve all member states) to produce the technical
-----The members of the
expert working group will be selected by the convenor member
-----experts within founding
parties or experts from other countries.
-- The Standing Committee
will organize conferences of the FHH dependent on FHH outcomes.
-- The conference will
be open to all interested parties and act as a venue for
-- information on projects
of the FHH.
-- Funding to support
the function and activities of the FHH will be sought from
-- parties, industry
associations and other organizations. Representatives of
member parties will fund
-- their own travel,
accommodation and related expenses to attend meetings. The
-- member will be responsible
for funding the secretariat support to the Standing Committee.
-- for sub-committees
and expert working groups is be provided by the convening