Regulatory requirements for vaccine authorisation.

ABSTRACT

Vaccines are one of the most important tools available in the prevention and control of diseases in animals. It is therefore of the utmost importance that when vaccines are used, such use should meet with the requirements of the World Organisation for Animal Health Terrestrial Animal Health Code and must be authorised by the recognised licensing body in the country/region where the vaccines are to be used, in accordance with the three key criteria of quality, safety and efficacy. This article provides a comprehensive and comparative description of the regulatory requirements in place for veterinary vaccines in major regions of the world, highlighting the similarities and pointing out also where there are differences. Recent advances in harmonisation of such testing requirements achieved through the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) are also described. The contents will provide a valuable guide to those engaged in the research and development of vaccines globally, and reassure those involved in the prevention and control of animal diseases that veterinary vaccines, when fully authorised and used according to the label instructions, are safe and efficacious.