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15/02/2022

International harmonisation of technical requirements for the registration of veterinary medicinal products (VICH)

For more information on the VICH

VICH is an international cooperation programme for the harmonisation of technical requirements for the registration of veterinary medicinal products. The Steering Committee shall include representatives of the competent authorities and the veterinary medicinal product industry of the United States, Japan and the European Union. Australia, Canada, New Zealand, South Africa and the United Kingdom have observer status for the Steering Committee. The Anses-ANMV, as the OIE Collaborating Centre for Veterinary Medicines, has been actively involved in this work as an associate member of the OIE since the creation of VICH in 1996.

The objectives of the VICH are to:

  • establish and implement harmonised technical requirements for the registration of veterinary medicinal products in VICH regions in order to meet strict standards of quality, safety and efficacy and to minimise the experimental use of animals and the cost of product development;
  • provide a basis for broader international harmonisation of registration requirements;
  • monitor and maintain existing VICH guidelines taking into account in particular the ICH work programme and, if necessary, update those VICH guidelines;
  • ensure efficient processes for the maintenance and monitoring of consistent interpretation of registration data following the implementation of VICH guidelines;
  • through constructive dialogue between regulators and industry, provide technical guidance to address key global emerging issues, as well as science, impacting regulatory requirements in VICH regions.

The VICH has thus drawn up 59 guidelines.

VICH decided to set up an expanded “VICH Outreach Forum” to bring together VICH members and non-member countries, in order to raise awareness of VICH, take into account their expectations and achieve greater international harmonisation of technical requirements for the registration of veterinary medicinal products. See the website “VICH Outreach Forum”.

The Enlarged Forum is composed of countries and regional organisations that have expressed interest in the work of VICH and are motivated to participate in the activities of the VICH Expanded Forum. Currently, approximately 14 countries and 4 regional organisations participate (or have been invited).

The VICH Expanded Forum meets in the margins of the VICH Steering Committee meetings held annually in one of the VICH member countries/regions. The Forum meetings are chaired by the VICH host country in collaboration with the OIE represented by Anses-ANMV, thereby recognising the OIE’s participation in VICH and its broader mandate.

All VICH and VOF reports can be accessed by following this link