Crinical Findings Using ECB and MLD Tests

ECB text

Recommendations published by WHO are intended to be scientific and advisory. Each of the following sections constitutes guidance for national regulatory authorities and for the manufacturers of biological products. If a national regulatory authority so desires, these Recommendations may be adopted as definitive national requirements, or modifications may be justified and made by the national re...

ECB text

ECB text

This document provides information and guidance to national regulatory authorities and vaccine manufacturers concerning the characteristics, production and control of inactivated oral cholera vaccines intended to facilitate progress towards their international licensure and use. The text is presented in the form of Guidelines instead of Recommendations because further work is still needed to de...

ECB text

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 ...

ECB Text 001-138

This document provides guidance to national regulatory authorities (NRAs) and vaccine manufacturers on the production and quality control of candidate live attenuated dengue virus vaccines by outlining the international regulatory expectations for product characterization. It should be read in conjunction with the WHO guidelines on nonclinical evaluation of vaccines (1), and the WHO guidelines ...