VICH is a trilateral (EU-Japan-USA) programme aimed at harmonising technical requirements for veterinary product registration. Its full title is the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. VICH was officially launched in April 1996. It has 5 main objectives.
The Objectives of VICH
The objectives of the VICH are along the same lines as those of the ICH. The VICH will:
- Establish and implement harmonized technical requirements for the registration of veterinary medicinal products in the VICH regions, which meet high quality, safety and efficacy standards and minimize the use of test animals and costs of product development.
- Provide a basis for wider international harmonization of registration requirements.
- Monitor and maintain existing VICH guidelines, taking particular note of the ICH work program and, where necessary, update these VICH guidelines.
- Ensure efficient processes for maintaining and monitoring consistent interpretation of data requirements following the implementation of VICH guidelines.
- By means of a constructive dialogue between regulatory authorities and industry provide technical guidance enabling response to significant emerging global issues and science that impact on regulatory requirements within the VICH regions.
The birth and scope of VICH
Preparatory work for the establishment of VICH was carried out by this OIE ad hoc group. Two meetings were held in 1994 and in 1995 at which the scope of the harmonisation project was discussed and the membership and objectives of the VICH proposed.
In defining the scope it was agreed that on the subject of food safety standards, which are the responsibility of Codex and JECFA, VICH would have a complementary role related to data requirements. Issues related to GLP and GMP, which are already the subject of mutual recognition agreements between countries, will not normally come within the remit of the VICH. Issues related to biologicals were considered appropriate to fall within the scope of VICH. Fundamental to the selection of priority topics for consideration by the VICH were:
- Identification of those ICH guidelines which could be adapted to the VICH programme;
- Identification of areas of non-harmonisation between the EU, the US and Japan and preparation of a series of “concept papers” on key topics; and
- Preparation of preliminary suggestions for priority topics.
Following completion of this preparatory work, the Steering Committee of the VICH held its first meeting in April 1996, at which the membership and the working procedures were agreed and a work programme established.
The historical background
The initiative to begin the harmonisation process came in 1983 when the first International Technical Consultation on Veterinary Drug Registration (ITCVDR) was held.
- The first International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was held in Brussels in November 1991. The meeting brought together regulators and industry representatives from the US, the EU and Japan to address quality, safety and efficacy requirements in the three regions.
- Meetings on harmonisation of veterinary biologicals were held in Ploufragan, France, in January 1992, in Arlington, US, in 1994 and in Singapore in 1995.
- In January 1993 the GHOST (Global harmonisation of standards) discussion document was published by FEDESA (the predecessor of AnimalhealthEurope). It set out a programme for the international harmonisation of registration requirements for veterinary pharmaceuticals and biologicals.
- Following discussions at ITCVDR and Office International des Epizooties (OIE) conferences, the OIE set up an ad hoc group on harmonisation of veterinary medicinal products in 1994.