WHO/BS/2016.2295 Requests to initiate new WHO reference material projects for vaccines and related substances
Document prepared by the WHO Secretariat, based on inputs from WHO Collaborating Centres supporting biological standardization activities
Overview
WHO biological reference standards are widely used in the development, evaluation, standardization and control of products by industry; by regulatory authorities; and also in biological research in academia and scientific organizations. They play a vital role in facilitating the transfer of laboratory science into worldwide clinical practice and the development of safe and effective biologicals.
Considerations for assignment of priorities to development of WHO International Biological Measurement Standards or Reference Reagents have been published (WHO TRS 932, Annex 2, Appendix 1, 2005). These considerations are used as guiding principles by the Secretariat and the WHO Collaborating Centres to develop a proposed programme of future work. To facilitate and to improve transparency in the priority setting process, a simple tool has been developed which describes the salient features of each new project proposal.
This document provides a means for the Committee and other stakeholders to review and comment on new proposals that are under consideration. The proposals in this document (WHO/BS/2016.2295) cover requests to initiate new projects in the areas of vaccines and related substances (Appendix 1).