International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products

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The aim of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) is to harmonize the requirements for drug approvals for veterinary medicinal products . It is a joint program of the European Union , Japan and the USA . It was officially launched in April 1996.

The program runs parallel to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and is strongly influenced by it.

history

In 1981, standardized requirements for drug approvals in veterinary medicine were introduced in Europe . With the International Technical Consultation on Veterinary Drug Registration (ITCVDR), efforts to achieve international harmonization in veterinary medicine began in 1983. Efforts to harmonize veterinary vaccines in France began in January 1992. The European Federation of Animal Health (FEDESA), a manufacturers' association for animal health , founded in Brussels in June 1987, is also doing preparatory work. Member companies included Alpharma , Bayer , Boehringer Ingelheim , Vetmedica , Cyanamid Fort Dodge, Eli Lilly International Corporation, Fatro , Gist-Brocades , Hoechst , Hoffmann-La Roche , Janssen Pharmaceutica, Merial , Monsanto Europe , Novartis , Pfizer , Pharmacia & Upjohn , Pliva , Sanofi , Schering , Vétoquinol and the national trade associations of the chemical and pharmaceutical industry, e.g. the Swiss Society for the Chemical Industry (SGCI) and the German Federal Association for Animal Health (BfT). In April 1996 the VICH program was started with the World Organization for Animal Health (OIE). The European umbrella organization of the animal health industry FEDESA (Fédération Européenne de la Santé Animale) decided in autumn 2002 to make its association independent in favor of integration into the International Federation for Animal Health Europe (IFAH-Europe) with effect from January 1, 2003.

Members and structure

Members

observer

Authorities and industry associations from Australia , Canada , New Zealand and, since 2013, South Africa are registered as observers .

patronage

The work of the VICH runs under the auspices of the World Organization for Animal Health (OIE). The OIE also informs the countries not involved in the process about the VICH results.

Work structures

A steering committee, made up of representatives of the member organization, acts as the highest body and controls the entire process and initiates individual work areas. The resulting working groups for the individual subject areas develop proposals for harmonization. They are usually chaired by a member of the steering committee. The guidelines developed from this, the VICH Guidelines , are to be incorporated into the respective national legislation in the VICH region once they have been adopted by the steering committee. When developing the guidelines, a constructive dialogue between the approval authorities and the industry is relied on. The organization of the VICH is incumbent on a secretariat, which is currently located at IFAH in Brussels .

tasks

The VICH process is predominantly based on the ICH procedure and includes the same work areas. In particular, the following tasks should be mentioned:

  • Development and introduction of harmonized requirements in the VICH region in order to obtain high and comparable standards and thus cost-saving, effective and safe veterinary medicinal products.
  • Development of a basis for the standardization of approval regulations.
  • Adaptation and adoption of ICH guidelines
  • Creation and maintenance of VICH guidelines , observation of the ICH program
  • Monitoring the implementation of VICH guidelines in the national regulations

Work areas

The current areas of work are: product quality , safety for humans and target animals, ecotoxicity , good clinical practice (GCP), anthelmintics , pharmacovigilance and residues / metabolic products .

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