WHO/BS/2015.2271 Requests to initiate new WHO reference material projects that have implications across a wide range of biologicals including therapeutics, blood-derived products, vaccines and immunological products

Overview

The provision of global measurement standards is an important normative activity of WHO. Biological reference preparations that are accepted internationally enable the efficacy, quality, purity and safety of very many biological medicines, used in the prevention, treatment or diagnosis of disease or conditions, to be stated in a common language worldwide. International biological reference standards support the use of many biological and immunological assays for the quality control of a wide range of biologicals including therapeutics, blood-derived products, vaccines and immunological products of traditional types as well as those derived from modern biotechnological approaches. They also have important applications in the standardization of materials and approaches used in medical diagnostics such as diagnosing disease, monitoring therapy, blood safety, and public health applications (e.g. monitoring immune status, screening for disease or susceptibility) or otherwise characterizing biological material from individuals.

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/2015.2271) cover requests to initiate new projects that potentially have implications across a wide range of biologicals including therapeutics, blood-derived products, vaccines and immunological products of traditional types as well as those derived from modern biotechnological approaches (Appendix 1).