Biologicals

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Biological Standardization

WHO Regulatory Standards for Vaccines and Biologicals

WHO has played a key role for over 50 years in establishing the WHO Biological Reference Materials necessary to standardize biological materials as well as developing WHO guidelines and recommendations on the production and control of biological products and technologies. These norms and standards, based on scientific consensus achieved through international consultations, assist WHO Member States in ensuring the quality and safety of biological medicines and related in vitro biological diagnostic tests worldwide. The Organization accomplishes this work through its biological programme, the WHO Collaborating Centers, and the WHO Expert Committee on Biological Standardization (ECBS). This also involves close collaboration with the international scientific and professional communities, regional and national regulatory authorities, manufacturers and expert laboratories worldwide.

Written guidance and reference materials

The activities of the WHO biological standardization programme include the development and establishment of written guidance and biological reference materials.

Written guidelines and recommendations describe procedures for the manufacture and quality control testing of biological medicinal products to ensure safe and effective products. Guidelines provide more general information on a range of topics of interest to National Regulatory Authorities (NRAs) and manufacturers, whereas recommendations establish the technical specifications for manufacturing and quality control of specific products. By adopting these guidance documents in their pharmacopoeias or equivalent legislation, national governments ensure that the products produced and used in their country conform to current international standards. Regulatory guidance documents also advise NRAs and manufacturers on the control of biological products, with the aim of establishing a harmonized regulatory framework for products moving in international markets.

Reference materials are required to standardize potency, purity, and identity measurements for complex biological materials. The WHO Biological Reference Materials provide a global standard against which experimental values can be compared and expressed, thereby allowing direct comparisons between products and measurements across different methodologies and assays in use around the world.

The unit within WHO Headquarters which has the primary responsibility for WHO's biological standardization programme is the Technologies, Standards and Norms (TSN).

TSN is located in the Essential Medicines and Health Products (EMP) within the cluster Health Systems and Innovation (HIS), The norms and standards (both written and biological) function is undertaken by a group of scientists who are responsible for WHO's biological standardization programme for vaccines and biotechnology products.The Coordinator of TSN serves as Secretary to the Expert Committee on Biological Standardization (ECBS).