Deadline for applications: 23 November 2020
1. The International Herbal Pharmacopoeia (IHP)
The objectives of the IHP are to:
- formulate an international pharmacopoeial standard by adapting and harmonizing selected monographic entries from existing NPHs/NHPs of different member states, as well as construction of de novo entries that will be recognized and accepted as a standard for promoting standardization of herbs/herbal products;
- contribute to ensuring the safety and quality of herbs/herbal products in the global market; and
- serve as a reference for Member States, which do not have a National Herbal Pharmacopoeia (NHP) or Herbal National Pharmacopoeia (HNP), to formulate their own standards or for adoption of the IHP as a formal safety and quality standard of herbs/herbal products, thereby strengthening the technical support of the WHO to Member States.
One of the missions of the WHO Traditional, Complementary and Integrative Medicine (TCI) is to support the development and finalization of the IHP through the WHO IHP secretariat, which it will establish.
2. Expert Committee for the International Herbal Pharmacopoeia (ECIHP)
The development of the IHP will be based on advice and recommendations from the Expert Committee for the International Herbal Pharmacopoeia (ECIHP) in line with rules and processes determined by the WHO. The inclusion of any herb or herbal product into the IHP remains the final decision of the WHO IHP secretariat based on the advice and recommendations made by the ECIHP.
2.1 Structure
2.1.1 The ECIHP will consist of three working groups (WGs), including:
- Herbs/herbal materials group (WG1);
- Herbal extracts/preparations group (WG2); and
- Finished herbal products group (WG3).
2.1.2 Each WG will consist of at least 10, but not more than 12, members appointed by the WHO IHP secretariat.
2.1.3 Each WG will consist of two group leaders appointed by the WHO IHP secretariat.
2.1.4 In addition to the WGs stated in item 2.1.1, any ad hoc sub-group may be appointed for a temporary duration by the WHO IHP secretariat for limited, specific and immediate purposes such as editorial review of documents before their submission to the WHO IHP secretariat.
2.1.5 A steering group (SG) will be established as an executive body of the ECIHP members who will be selected from the three WGs by the WHO IHP secretariat.
2.1.6 The WHO IHP secretariat will appoint a chair and two co-chairs of the ECIHP who will also chair the SG.
2.2 Composition
2.2.1 Members of the ECIHP will be selected primarily from countries across the six WHO regions, where—
- herbs/herbal products are popularly used; and
- the national/regional pharmacopoeias including herbs/herbal products (NPHs) or national herbal pharmacopoeias (NHPs) are relatively well developed.
2.2.2 ECIHP members should possess expertise and extensive experience in pharmacopeia review, drafting and/or applications in terms of herbs/herbal products.
2.2.3 Notwithstanding 2.2.1, ECIHP members may be selected from the rosters of, the WHO Expert Advisory Panel on traditional medicine, WHO TCI collaborating centers, WHO IRCH, or from other relevant organizations or institutions, including national/regional regulatory agencies, national/regional pharmacopoeia commissions/committees, national administration of traditional medicines, academic institutions and associations, among others.
2.3 Objectives and Tasks
2.3.1 The three WGs are expected to make recommendations related to the most appropriate methods and procedures for the establishment of relevant IHP content including monographs, general notices, general chapters for general test/analytical methods, dosage form descriptions and necessary appendices.
2.3.2 The tasks of WG members will include, but not be limited to:
- Reviewing and reporting any advice or recommendations regarding any inclusions to the IHP;
- Periodically reviewing, discussing and commenting on the protocols of monographs and general test/analytical methods in the IHP completed by laboratories and institutions;
- Developing general notices and general chapters for dosage forms as well as populating appendices where required (e.g. lists of reagents, markers used in the monographs) in the IHP;
- Supplementing and finalizing the list of herbs/herbal materials, herbal preparations and herbal finished products, the list of general test/analytical methods, identified by WHO IHP secretariat; and
- Attendance of meetings including teleconferences as may be required.
2.3.3 WG members who are participating in laboratory research may draft monograph(s) or general test/analytical methods as per WHO IHP technical guidelines. These members will be requested to agree not to comment on their draft documents or any other documents from the same laboratory in writing or WG meetings.
2.3.4 WG members from WHO laboratory centers of reference standards will be responsible for the coordination of relevant laboratory centers, the WHO IHP secretariat and other stakeholders to ensure the timely availability and distribution of the reference standards being used in the development of the IHP.
2.3.5 WG leaders are responsible for the coordination within the individual group, and for coordinating the joint meetings or interactions with the SG and/or other WGs when necessary.
2.4 Duration of appointment
2.4.1 The first session of the ECIHP will last for two years.
2.4.2 Subsequent ECIHP sessions will renew every three years.
2.4.3 Applications for membership of the ECIHP will be requested by the WHO IHP secretariat for each session of the ECIHP as may be necessary.
2.4.4 The first session of the ECIHP will draw on members from applications received by the WHO IHP secretariat.
2.4.5 With respect to subsequent ECIHP sessions the WHO IHP secretariat may —
- reappoint members from previous sessions based on satisfactory performance in the previous sessions and need of the WHO IHP secretariat; and
- appoint additional members as a result of any new application made in terms of paragraph 2.4.3.
3. Members of the ECIHP
Membership criteria as well as the application and selection process is prescribed by the WHO IHP secretariat.
3.1 Criteria for Membership
3.1.1 ECIHP members should possess the expertise and extensive experience associated with pharmacopeia review and development and/or related applications in terms of herbs/herbal products.
3.1.2 The members of the ECIHP are required to have at least 10 years’ work experience in the disciplines related to herbal pharmacopoeia standards or herbal quality standards such as botany, pharmacognosy, phytochemistry, analytical chemistry, molecular biology, herbal material processing or phytopharmaceutical manufacturing.
3.1.3 Herbal professionals are expected to hold a senior title or position with the requisite experience demonstrable in their CVs.
3.1.4 The following candidates will be prioritized for consideration and appointment as members of the ECIHP:
- Experts from the WHO Expert Advisory Panel on traditional medicine or WHO TCI collaborating centers, who are familiar with pharmacopoeia and herbal quality standards;
- Members in the current session of national/regional pharmacopoeia commission/committee with respect to herbs/herbal products; and
- Experts who have made significant contributions to national/regional pharmacopoeias in terms of herbs/herbal products or herbal quality.
3.2 Application for Membership
3.2.1 Announcements for applications for ECIHP membership, including application forms and relevant guidelines, will be—
- placed online on the WHO TCI website;
- notified to all six WHO regional offices by the WHO IHP secretariat at least 30 days prior to each session of ECIHP membership; and
- notified to the relevant national organizations or institutions in item 2.2.3 by WHO country offices.
3.2.2 Unless otherwise expressly indicated by the WHO IHP secretariat in writing, only applications received before the stated deadline for the respective ECIHP session will be considered.
3.2.3 Individuals may apply for ECIHP membership by way of one of the following ways:
- Governmental recommendation or nomination - Membership candidates may be proposed by a national/regional governmental agency associated with the development or maintenance of pharmacopoeia or associated standards such as a drug regulatory agency, traditional medicine administration agency, national/regional pharmacopoeia body covering traditional medicines or national/regional traditional medicinal pharmacopoeia body. Members who were proposed by their national/regional governmental agencies shall be considered as representing their countries/regions on the ECIHP.
- Voluntary individual application - Membership candidates may personally express interest in becoming the members of the ECIHP by way of voluntary application and submission of required supporting materials to the WHO IHP secretariat. Members who have applied by way of voluntary individual applications shall be considered to represent their own expert opinions and not those of their countries/regions when expressed on the ECIHP.
- WHO Invitation - The WHO IHP secretariat may identify suitably qualified candidates and nominate such individuals for membership of the ECIHP following consensus reached with relevant stakeholders and partners. Membership candidates identified in terms of item 3.3.1 will be formally notified in writing thereof and invited to submit the relevant application documents as determined by the WHO IHP secretariat.
3.2.4 All applications for ECIHP membership must include:
- a cover letter or evidence of nomination/request where relevant;
- the WHO application form (Annex 1);
- the candidate’s CV/bio sketch (Annex 2); and
- any other required form or information as may be required by the WHO.
3.3 Appointment of members
3.3.1 The appointment of an ECIHP member by the WHO IHP secretariat is subject to the review of the application materials received and relevant selection criteria as determined by the WHO following the WHO normal protocols/procedures.
3.3.2 The WHO IHP secretariat shall collect and review all application materials submitted and develop an ECIHP member candidate shortlist.
3.3.3 The WHO IHP secretariat shall select and appoint three members of the ECIHP who, subject to their acceptance, shall be designated as the chair and co-chairs of the ECIHP and SG.
3.3.4 After consultation with the chair and co-chairs, the WHO IHP secretariat will proceed to appoint all remaining members of the ECHIP from across the six WHO regions and to select members of the steering group (SG).
3.4 Public Statement of ECIHP Members/Activities
Names and relevant designations of ECIHP members, as well as any meetings and official final documents of the ECIHP, may be published on the WHO website, WHO IRCH platforms or related WHO communications.