6952 Ece Text

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 vaccine evaluation. Vaccines are a diverse class of biological products and their nonclinical testing programmes will depend on product-specific features and clinical indications. The following text has therefore been written in the form of guidelines rather than recommendations. Guidelines allow greater flexibility than recommendatisons with respect to specific issues related to particular vaccines.