Peer-reviewed veterinary case report
Regulatory requirements for vaccine authorisation.
- Journal:
- Revue scientifique et technique (International Office of Epizootics)
- Year:
- 2007
- Authors:
- Jones, P G H et al.
- Affiliation:
- International Federation for Animal Health
Plain-English summary
Vaccines are crucial for preventing and controlling diseases in animals, and it's very important that they meet specific standards before being used. These standards are set by the World Organisation for Animal Health and require that vaccines are approved by the appropriate licensing authority in each country or region. The article discusses the rules for veterinary vaccines around the world, noting both the similarities and differences in these regulations. It also highlights recent efforts to make these testing requirements more consistent internationally. Overall, the information aims to reassure those involved in animal health that properly authorized vaccines are safe and effective when used as directed.
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.
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Search related cases →Original publication: https://pubmed.ncbi.nlm.nih.gov/17892159/