WHO/BS/2014.2243 Requests to initiate new WHO reference material projects for vaccines and related substances; for cytokines, growth factors and endocrinological substances; and for antibiotics
Document prepared by the WHO Secretariat, based on inputs from WHO Collaborating Centres supporting biological standardization activities.
Overview
The timely development of new reference materials and standards is critically important to harness scientific developments for new biologicals. At the same time, the active management of the existing inventory of reference preparations requires a carefully planned programme of work to replace established materials before the stock of containers, which comprises the standard, is exhausted.
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/2014.2243) cover requests to initiate new projects in the areas of vaccines and related substances, biotherapeutic products and antibiotics (Appendix 1).