Duration of protection in animals: the point of view of regulators.
In Europe, two main regulatory texts regulate the immunogenicity requirements of vaccines, the European Pharmacopoeia and the guidelines of the European Medicines Evaluation Agency (EMEA). This article outlines these requirements and the regulatory challenges.
Bruckner
L
L
Institute of Virology and Immunoprophylaxis, CH-3147 Mittelhäusern, Switzerland. lukas.bruckner@ivi.admin.ch
D000818:Animals; D005060:Europe; D007880:Legislation, Drug; D014611:Vaccination / Q000331:legislation & jurisprudence* / Q000662:veterinary*; D014612:Vaccines / Q000276:immunology*
D014612:Vaccines