Role of VICH

What is the role of VICH

The role of VICH is to harmonise technical requirements for data necessary for the marketing authorisation (also called “registration”) of a veterinary medicinal product.  This is achieved by developing harmonised guidelines on the studies to be submitted in a marketing authorisation application.

Typically a VICH guideline describes how a study should be conducted to satisfy quality, safety or efficacy data requirements. VICH also covers data requirements for post-marketing pharmacovigilance systems. The benefit of having harmonised guidelines is to avoid studies being duplicated or repeated. 

It is NOT the role of VICH to:

• Provide guidance to establish regulatory systems and regulations for marketing authorisations,
• Decide which studies are necessary to obtain a marketing authorisation,
• Assess data or provide guidance on the assessment approach,
• Grant marketing authorisations,
• Establish safety standards.

These are typically the roles of national competent authorities and governments.

For more information, please download the VICH Leaflet “Harmonising the global processes for authorising veterinary medicines“.

Which areas do VICH guidelines cover?

In the period from its establishment in 1996 to November 2023 VICH has completed in total 60 harmonised guidelines, with further 6 guidelines in preparation. The guidelines cover the areas:

• For pharmaceuticals: quality, safety (toxicology, target animal safety, antimicrobial safety, environmental safety and residues) and efficacy.
• For biologicals: quality, target animal safety and batch safety testing.
• In addition there is one general guideline on good clinical practice (GCP), one general guideline on Electronic File Format, one guideline on Bioequivalence and there are 5 VICH Pharmacovigilance guidelines.

For further details and to download the guideline texts go to the GUIDELINES page.

Process to develop guidelines

The VICH guidelines are developed by expert working groups comprising experts from the VICH Founding and Standing members, the observers and from VICH Outreach Forum countries on topics identified by the VICH Steering Committee in a consultative process, and are adopted by the Steering Committee.

Countries that are not part of VICH can send comments that respond to draft VICH guidelines during the public consultation (step 4 of the VICH process).  The draft guidelines will be distributed by WOAH to the WOAH veterinary products focal points.

For further details go to the PROCESS page.