What is the VICH Outreach Forum
What is the VICH Forum?
The VICH Forum is a VICH initiative with the main objective of providing a basis for wider international harmonization of technical requirements, improve information exchange and raise awareness of VICH and VICH guidelines with non-VICH countries/regions.
- TERMS OF REFERENCE (VICH/11/010-rev 3-June 2023-fin)
- VICH FORUM APPLICATION FORM (VICH/19/068)
The Forum is composed of countries and regional organisations that have expressed an interest in the work of VICH and are motivated to participate in the activities of the VICH Forum. Currently approximately 18 countries and 4 regional organisations are participating (or have been invited).
The VICH Forum meets in the margins of VICH Steering Committee meetings, which take place one per year in one of the VICH member countries/regions. The Forum meetings are chaired by the VICH host country in collaboration with WOAH, recognising the WOAH’s membership in VICH as well as its broader mandate.
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Background and objectives
This page also contains information on Forum composition, venue and discussion points.
Background
The VICH Organisational Charter states in its objectives that as well as establishing and implementing harmonised technical requirements for the registration of veterinary medicinal products in the VICH regions, the programme should “work towards providing a basis for wider international harmonisation of technical requirements”.
Objective
The main objective for the VICH Forum is to provide a basis for wider international harmonization of technical requirements, improve information exchange and raise awareness of VICH and VICH guidelines with non-VICH countries/regions. The over-reaching aim is to avoid the duplication of tests and encourage a minimum standard of product ‘quality’ (includes quality, safety and efficacy), while also promoting the good governance of veterinary medicinal products worldwide.
Composition
The VICH Steering Committee highlighted this objective in the VICH priorities for the years 2011-2015 as set out in its Strategy for Phase III: 2011-2015. The Steering Committee decided to set up a ‘VICH Forum’ composed of:
- representatives from regulatory authorities of non-VICH countries and regions invited by the VICH Steering Committee on the basis of agreed criteria, and
- representatives from the Steering Committee and WOAH.
The VICH Forum is a VICH initiative, and will be chaired by VICH in collaboration with WOAH, recognising the WOAH’s membership in VICH as well as its broader mandate.
The VICH Forum will meet in the margins of VICH Steering Committee meetings, which take place once per year in one of the VICH member countries/regions. Matters identified that will be addressed at the VICH Forum will be:
- Information exchange on how to participate in VICH work, such as proposing topics and commenting on concept papers and draft guidelines.
- Discussing feedback to VICH concept papers and draft guidelines
- Providing feedback on implementation and acceptance of existing guidelines
- Discussing practical issues related to VICH guidelines arising in the participants’ countries/regions and providing feedback to the Forum.
- Collaborating and sharing of translations of guidelines.
Concept papers and draft guidelines for consultation will continue to be distributed to non-VICH countries and regions through WOAH and the VICH website.
In light of the discussions at the Forum meetings the VICH Steering Committee will review other questions arising and may add or amend tasks and roles or composition of the Forum.
Membership
Representatives from the regulatory authorities and from the industry organisations of the following countries and regional organisations participate in, or have participated in VICH Forum:
Argentina (SENASA, CAPROVE)
ASEAN
Botswana
Brazil
Brunei
Burkina Faso
CAMEVET
People’s Republic of China
EAC
Egypt
India
Korea
Malaysia
Mexico
Morocco
Nigeria
Rwanda
Russia
SADC
Saudi Arabia
SINDAN
Singapore
Taipei
Taiwan
Tanzania
Thailand
The Philippines
UAE
UEMOA
Uganda
Ukraine
Zambia
Zimbabwe
Other countries or regional organisations that are interested in participating in this initiative should write to the VICH secretariat: sec@vichsec.org
The criteria for participation in the VICH Form are:
- Regulation for marketing authorisation in place;
- Willingness to work towards accepting and implementing VICH guidelines;
- Paying for participation (travel costs, accommodation and translation, if needed);
- Regular participation.
How to participate
VICH Forum members can participate in the VICH activities in the following ways:
- Participation in the Forum meetings (see ‘Terms of Reference for the VICH Forum’).
- Proposals for new topics; a Forum member can draft a discussion document or a Concept Paper with the assistance of a member of the VICH Steering Committee (see ‘Note to prepare a VICH Topic Concept Paper’).
- Provide feedback on the relevance of and on the implementation of VICH guidelines in your country and region.
- Where relevant, participate in VICH Expert Working Groups (see ‘Criteria for participation of VICH Forum members in VICH Expert Working Groups’). If you join an Expert Working Group, the VICH Secretariat will send further information on the working group procedures.
- Submit comments to draft guidelines during the public consultation phase (step 4 of the VICH process).
- Make suggestions for discussion at the VICH Forum meetings.
- Provide feedback on the usefulness of the VICH Forum and the VICH webpages.
Countries that are not members of VICH or of the VICH Forum can contribute to the VICH process in the following ways:
- Submit comments to draft guidelines during the public consultation phase (step 4 of the VICH process). The draft guidelines will be distributed by WOAH to the WOAH veterinary products focal points.
How to implement
VICH guidelines are documents that explain to companies/organisations interested in obtaining a marketing authorisation (also called registration) for veterinary medicines how to generate the experimental data necessary to support the application.
The VICH Founding member countries / regions have the obligation to implement the adopted VICH guidelines as technical requirements for the authorisation of veterinary medicinal products in their country/region. The VICH Standing member countries/regions are committed to implement the adopted VICH guidelines to the fullest extent possible.
The use of the VICH guidelines is not restricted to the countries and regions affiliated with VICH. Any country or regional organisation, any regulatory system that requires submission of experimental data in support of applications for the granting of marketing authorisation for veterinary medicines can make use of VICH guidelines. Indeed, countries and regions are invited to do so, as it would multiply the benefits in respect of reducing the use of animals in the generation of data for regulatory submissions and in respect of a reduction of duplication of work.
The VICH guidelines are publicly available through the VICH website. They are also published on the websites of the regulatory authorities of the VICH Founding and Standing members.
There are different ways that technical guidelines such as the VICH guidelines can be implemented. It is the decision of the country or region and may depend on how the legislation in the country/region has been set up. Normally VICH countries and observers use them as separate technical guidelines in support of legislation without making them a part of the legislation (legally non-binding).
If a country or region considers implementing VICH guidelines, it should bear in mind that it is not necessary to implement all the guidelines as a package, but a country or region may choose to implement only selected guidelines, e.g. the most needed or suitable guidelines, or may consider a stepwise implementation process.
The VICH member countries and regions are obliged to implement the VICH guidelines as adopted, and it is encouraged that also other countries using VICH guidelines would use them unchanged.
It is however recognised that a country or region that was not part of the VICH process developing the guideline, may find that it can apply the main part of a VICH guideline, but specific required details may need to be adapted to the specificity of local conditions, such as the specific animal diseases or animal species relevant for that country /region. In such a case a VICH guideline can be implemented adapted, to the minimum extent necessary, to fit local conditions.
In the interest of promoting harmonisation of technical requirements for the registration of veterinary medicinal products, VICH would encourage the widest use possible of its guidelines, with the minimum changes only when absolutely necessary to adapt the guidelines to local conditions.
Feedback to VICH on which guidelines have been implemented in your region, and how they were implemented would be greatly appreciated.