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Understanding VICH

• Formation
• Steering committee & objectives
• VICH working groups (process & topics)
• Role of OIE
• Finalised polices (link to VICH)
• Draft polices

Formation of VICH

The formation of the Veterinary International Cooperation on Harmonisation (VICH) stems back to 1983 when the United States Food and Drug Administration hosted the first International Technical Consultation on Veterinary Drug Registration (ITCVDR).

In 1994, the International Office of Epizootics (OIE) set up an ad hoc group to discuss the scope, membership and objectives of the proposed VICH. In setting up the VICH, the OIE ad hoc group has drawn on the experience of the human pharmaceutical harmonisation initiative and used this International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as a model.

With respect to food safety standards, the VICH complements the work of Codex and JECFA.

VICH Steering Committee

Membership of VICH SC
(number of seats)

The VICH SC meets twice a year on a rotational basis in participating member countries.

Objectives of VICH

• Provide a forum for a constructive dialogue between regulatory authorities and the veterinary medicinal products industry on the real and perceived differences in the technical requirements for product registration in the EU, Japan and the USA, with the expectation that such a process may serve as a catalyst for a wider international harmonisation.
• Identify areas where modifications in technical requirements or greater mutual acceptance of research and development procedures could lead to a more economical use of human, animal and material resources, without compromising safety.
• Make recommendations on practical ways to achieve harmonisation in technical requirements affecting registration of veterinary products and to implement these recommendations in the three regions. Once adopted the VICH recommendations should replace corresponding regional requirements (for member countries). These recommendations should focus on the essential scientific requirements needed to address a topic and should eliminate unnecessary or redundant requirements.
• The VICH should be conducted in a transparent and cost-effective manner and should provide the opportunity for public comment on recommendations at the draft stage.

VICH Working Groups

The VICH SC appoints Working Groups of experts to consider specific topics, and draft recommendations to assist the harmonisation process. Guidelines developed by the working groups follow a nine-step procedure.

Step 1: The steering Committee defines a priority item from a concept paper prepared by a member and appoints a working group if needed. A topic leader is given a mandate to draft a recommendation.

Step 2: A recommendation is drafted by the working group.

Step 3: The draft is submitted to the Steering Group for approval.

Step 4: Following adoption by the Steering Group, the draft recommendation is circulated for consultation.

Step 5: The working group takes comments into consideration in preparing a revised draft. The topic leader must be a representative of a regulatory authority at this stage.

Step 6: The revised draft recommendation is submitted to the Steering Group for approval.

Step 7: A final recommendation and proposed implementation date are circulated to the relevant regulatory authorities.

Step 8: Steering Group members report back on the implementation progress in their regions.

Step 9: Recommendations may be revised at the request of a member to take into account new scientific evidence.

The following topics are being or have been addressed by the Working Groups:

• Quality guidelines
  (related to stability, validation, impurities).
• Safety guidelines
  (related to genotoxicity and reproduction toxicity).
• Good Clinical Practice.
• Efficacy Requirements for anthelmintics.
• Ecotoxicity/environmental impact assessment.
• Pharmacovigilance,
• Biologicals quality monitoring
• Target Animal Safety, and
• Antimicrobial Resistance.

Role of OIE

The OIE will act as a forum for the dissemination of VICH guidelines. While these guidelines are being developed to satisfy requirements in three main regions, other countries are welcome to adopt them, but are not required to do so.

Finalised VICH Policies

• GUIDANCE FOR MEMBERS OF VICH WORKING GROUPS (VICH/00/150 25 April 2001 Final)
• POLICY ON APPRECIATION SHOWN TO THE CHAIRS AND WORKING GROUP MEMBERS (VICH/00/155 25 April 2001 Final)
• POLICY FOR DISBANDING WORKING GROUPS (VICH/00/153 7 March 2001 Final )
• GUIDANCE FOR THE STEERING COMMITTEE ON THE APPOINTMENT OF EXPERTS AND CHAIRPERSONS/TOPIC LEADERS TO WORKING GROUPS - (VICH/00/152 25 April 2001 Final)
• SOP ON VICH PROCEDURE FOR THE WORKING GROUPS (VICH/00/151 25 April 2001 Final)

More information is available on the VICH international website.

Draft VICH Policies

• DRAFT POLICY PAPER FOR THE ACCEPTANCE OF INTERESTED PARTIES IN VICH STEERING COMMITTEE MEETINGS (VICH/00/117 31 January 2001 Draft 4)