International harmonisation of regulatory requirements

M Holmes, R E Hill
2007 Rev Sci Tech Off Int Epizoot  
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
more » ... ents 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.
pmid:17892161 fatcat:5vpqryqty5hrrkbyvmknqeltvy