This document provides guidance to national regulatory authorities (NRAs) and vaccine manufacturers on the nonclinical evaluation of vaccines by outlining the international regulatory expectations in this area. It should be read in conjunction with the Guidelines on clinical evaluation of vaccines: regulatory expectations (1), in order to complete the understanding of the whole process of vacci...

In recent years, technologically advanced high-throughput techniques have been developed that replace, reduce or refine animal use in vaccine quality control tests. Following validation, these tests are slowly being accepted for use by international regulatory authorities. Because regulatory acceptance itself has not guaranteed that approved humane methods are adopted by manufacturers, various ...

In this chapter the authors provide evidence of the effectiveness of European National Regulatory Authorities in applying the basic principles of the ladder of investment. The analysis discusses and compares the regulatory approach adopted in 12 European Countries from January 2005 to July 2007. Results are not easy to interpret, given the peculiarities of the different national markets. Nevert...

In August 2000, health authorities in England and Wales became statutory consultees for permits issued to industry by the Environment Agency as part of the implementation of EU directives. This responsibility has since been delegated to Primary Care Trusts. To assess health authority responses to applications made under the Integrated Pollution Prevention and Control (IPPC) regulations, we coll...