International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)

Bringing together the veterinary medicines regulatory authorities and pharmaceutical industry of Europe, Japan, and the United States, the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) aims to achieve greater harmonisation worldwide for the development and approval of safe, effective, and high quality veterinary medicines in the most resource-efficient manner. The European Medicines Agency (EMA), alongside the European Commission, is a member of VICH's steering committee.

The role of VICH is to harmonise technical requirements for data necessary for the authorisation of veterinary medicines.

VICH achieves this through developing harmonised guidelines on the studies to be submitted in a marketing authorisation application. Typically a VICH guideline describes how to conduct a study to satisfy quality, safety or efficacy data requirements.

VICH also covers data requirements for post-authorisation pharmacovigilance systems.

The objectives and activities of VICH are similar to those of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

EMA role

The VICH steering committee, which is responsible for agreeing and prioritising topics and sourcing experts for guideline development and approval, includes an EMA representative and the chair of EMA's Committee for Medicinal Products for Veterinary Use (CVMP).

The EMA representative acts as coordinator for VICH activities in the EU and plays a key role in ensuring that EU contributions to VICH topics are developed and communicated in a timely manner.

In addition, all VICH expert working groups include EU experts nominated by the CVMP. These experts can chair relevant working groups or lead the development of particular guidelines.