International harmonisation of regulatory requirements.

Abstract

The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) was formed in April 1996 and is a programme of collaboration between regulatory authorities and the animal health industries of three world regions: the European Union, Japan and the United States of America. Two other regions, Canada and Australia/New Zealand, have observer status. The principal goal of VICH is to harmonise technical data requirements of participating regulatory authorities before granting marketing authorisation or registration. VICH has finalised six guidelines on the technical requirements for marketing authorisation/registration of biological products. These guidelines have been fully implemented in the regions. Three more technical guidelines are under development by two expert working groups. VICH has also finalised a guideline which specifically deals with pharmacovigilance and veterinary medicinal products, including biological products. A further four guidelines relating to pharmacovigilance are under development by an expert working group.