Guidelines on clinical evaluation of vaccines: regulatory expectations, Annex 1 , TRS No 924

Overview

This document provides guidance for national regulatory authorities and vaccine manufacturers on the clinical evaluation of vaccines by outlining the international regulatory expectations applicable to the different stages of vaccine
development and for marketing approval. For this reason, the guidance in this document could also be useful for clinical researchers and investigators.

The text is presented in the form of guidelines rather than recommendations because vaccines are a heterogeneous
class of agents, and the preclinical and clinical testing programmes will need to be adapted for each individual
product. Guidelines allow greater flexibility than recommendations with respect to specific issues related to particular vaccines. A separate WHO document intended to provide more detailed guidance on preclinical and laboratory evaluation of vaccines is in preparation. This was subsequently established by the 54th meeting, November 2003, of the WHO Expert Committee or Biological Standardization and is to be published in the WHO Technical Report Series. The section of this document that discusses preclinical and laboratory evaluation consequently provides general guidance, but does not define international regulatory expectations in this area.