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Guidelines on clinical evaluation of vaccines: regulatory expectations

This document provides guidance for national regulatoryauthorities and vaccine manufacturers on the clinical evaluationof vaccines by outlining the international regulatoryexpectations applicable to the different stages of vaccinedevelopment and for marketing approval. For this reason,the guidance in this document could also be useful for clinicalresearchers and investigators.The text is presented in the form of guidelines rather thanrecommendations because vaccines are a heterogeneousclass of agents, and the preclinical and clinical testingprogrammes will need to be adapted for each individualproduct. Guidelines allow greater flexibility than recommendationswith respect to specific issues related to particularvaccines.A separate WHO document intended to provide more detailedguidance on preclinical and laboratory evaluationof vaccines is in preparation. This was subsequentlyestablished by the 54th meeting, November 2003, of theWHO Expert Committee or Biological Standardization andis to be published in the WHO Technical Report Series. Thesection of this document that discusses preclinical andlaboratory evaluation consequently provides general guidance,but does not define international regulatory expectations inthis area.


This document provides guidance to national regulatory authorities(NRAs), manufacturers, clinical researchers and investigators on theclinical evaluation of vaccines by outlining the data that should beobtained during the different stages of vaccine development to supportan application for marketing approval. This document has beenprepared in response to requests from NRAs for assistance in theevaluation of clinical trials, both during the clinical development of anew vaccine and during the regulatory review of dossiers submitted insupport of applications for marketing authorization. The NRAsECB text 36 19/11/2004, 09:48 AMBlack37Gshould have a mandate to review protocols, and when this is necessaryto protect the safety of subjects, to require revision of the protocoland/or termination of the trial. This document is intended to providebasic guidance to NRAs on how to achieve these objectives. Becauseit is common practice for the clinical development programmes andthe individual clinical trials to take place in different countries, eachNRA should, as far as possible, collaborate with the other regulatoryauthorities involved to benefit from shared experiences and to alignregulatory considerations (1)...

For more information, please refer to: http://www.who.int/biologicals/publications/trs/areas/vaccines/clinical_evaluation/035-101.pdf