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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:
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.
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.
Issues related to herbal medicines are complex and numerous. The FHH should commence focus on issues:
A member party will be appointed by the Standing committee as 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.
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 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 website, publicizing regional guidelines).
Reports of sub-committees will be transmitted to the secretariat of Standing Committee for filing and necessary action.
Members 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 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
The convenor member of sub-committee has the authority set up expert working group(s) in special areas identified by sub-committees. The 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.
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 dissemination of information on projects of the FHH.
Funding to support the function and activities of the 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 be provided by the convening member party.