VICH Structure
Overview of VICH Structure
The parties to VICH
Founding members
The principle parties to VICH are regulatory and industry organisations from the 3 VICH regions. The 6 parties to VICH and members of the steering committee are:
- European Union
- European Commission and European Medicines Agency (EMA)
- AnimalhealthEurope representing industry
- USA
- US Food & Drug Administration – Center for Veterinary Medicine (CVM) and US Department of Agriculture – Center for Veterinary Biologics (USDA/CVB)
- US Animal Health Institute (AHI) representing industry
- Japan
- Ministry of Agriculture, Forestry and Fisheries (JMAFF)
- Japanese Veterinary Products Association (JVPA) representing industry
Standing members
The following regulatory and industry organisations are standing members (previously Observers) to the VICH process:
- Australia
- Australian Pesticides and Veterinary Medicines Authority (APVMA)
- Animal Medicines Australia (AMA) representing Industry
- New Zealand
- New Zealand Ministry for Primary Industries
- Animal and Plant Health New Zealand representing industry
- Canada
- Health Canada (HC) – Veterinary Drugs Directorate (VDD) and Canadian Center for Food Inspection Agency (CFIA) – Veterinary Biologics Section (CCVB) (1)
- Canadian Animal Health Institute (CAHI) (1) representing industry
- South Africa
- Department of Agriculture, Forestry and Fisheries (DAFF) and South African Health Products Regulatory Authority (SAHPRA), South Africa (1)
- South African Animal Health Association (SAAHA) (1) representing industry
- United Kingdom
- Veterinary Medicines Directorate (VMD)
- National Office of Animal Health (NOAH) representing industry
Observers
- AVBC
- Switzerland: Swissmedic / Scienceindustries
Associate member
WOAH: World Organisation for Animal Health
Secretariat
Summary of the composition of the steering committee (and number of seats)
| Founding Members of the Steering Committee | ||
| European Union | USA | Japan |
| European Commission (1) EMA (1) AnimalhealthEurope (2) | FDA/CVM (1) USDA/APHIS (1) AHI (2) | JMAFF (2) JVPA (2) |
| Standing Members of the Steering Committee | ||||
| Australia | New Zealand | Canada | South Africa | United Kingdom |
| APVMA (1) AMA (1) | APHANZ (1) MPI (1) | Health Canada (1) CAHI (1) | DAFF/SAHPRA(1) SAAHA (1) | VMD (1) NOAH (1) |
Observers to the Steering Committee
Switzerland
Swissmedic (1)
Scienceindudstries (1)
Associate Member
WOAH (1)
The Steering Committee
The VICH Steering Committee has the decision making role and is the driver of the harmonisation process. The Steering Committee is composed of two delegates of the regulatory authorities and two delegates of representative industry associations from the three regions. Australia/New Zealand, Canada, South Africa and the UK have Standing member status with one delegate representing government authorities and one delegate representing industry associations. WOAH, the associate member, has one delegate (see also “Overview of VICH Structure“).
New VICH guidelines topics are proposed by members of the Steering Committee. If the new topic is approved by the Steering Committee then a topic leader within the Steering Committee is appointed which will usually be the original proposer of the topic, and normally the chair of the corresponding expert working group will come from the same country or region as the Steering Committee topic leader (see also “VICH Process“).
Expert Working Groups and Observers
Expert Working Groups (EWGs) and topic leaders
In order to achieve harmonisation on the selected topics, the VICH Steering Committee will appoint EWGs to draft guidelines. Each EWG will normally comprise a minimum of six experts – one representing each VICH full member. Each member may send one additional advisor to participate and the Steering Committee may, depending on the expertise required, decide to allow the appointment of more than one expert per VICH member. Additional experts from Standing member countries or VICH Forum member countries may also be appointed by the Steering Committee if deemed appropriate.
A chairperson will be appointed by the Steering Committee (normally from the same country or region as the Steering Committee topic proposer). The chairperson is responsible for initiating and guiding the work within the EWG. He/she will be accountable to the Steering Committee for delivering the draft and will be responsible for reporting to the Steering Committee.
Related topics may be covered by a single EWG. In this case a topic leader will be assigned for each additional topic.
Standing members
Government and industry representatives from Australia/New Zealand, Canada, South Africa and the UK are participating as Standing members in the working process of the Steering Committee. As Standing members they may join in Committee discussions and send experts to the EWGs, although they have no voting rights. While they are not bound by the VICH recommendations, they are encouraged to take them into account in due course.
The WOAH
The VICH has been established under the auspices of the WOAH. WOAH provides support to VICH and encourages its member countries to take into consideration the VICH results by providing ongoing information on the progress of VICH and consulting them on draft VICH guidelines. WOAH also circulates the final VICH guidelines.
The VICH Secretariat (HealthforAnimals)
HealthforAnimals fulfils the role of VICH Secretariat. This includes the preparation of documents for VICH Steering Committee and Forum meetings, publishing guidelines adopted by the Steering Committee and ensuring a smooth and continuous functioning of the VICH process. The Secretariat is the contact point for any questions regarding VICH.