WHO/BS/2016.2297 Requests to initiate new WHO reference material projects for blood products
Document prepared by the WHO Secretariat, based on inputs from WHO Collaborating Centres supporting biological standardization activities.
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.
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.
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/2016.2297) cover requests to initiate new projects in the areas of blood products.