WHO Expert Committee on Biological Standardization: sixty-eighth report

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances, and the establishment of international biological reference materials.

WHO Guidelines on the quality, safety and efficacy of Ebola vaccines, and WHO Guidelines on procedures and data requirements for changes to approved biotherapeutic products were adopted on the recommendation of the Committee. In addition, the following two WHO guidance documents on the WHO prequalification of in vitro diagnostic medical devices were also adopted: (a) Technical Specifications Series (TSS) for WHO Prequalification - Diagnostic Assessment: Human immunodeficiency virus (HIV) rapid diagnostic tests for professional use and/or self-testing; and (b) Technical Guidance Series (TGS) for WHO Prequalification - Diagnostic Assessment: Establishing stability of in vitro diagnostic medical devices. Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: antibiotics, biotherapeutics other than blood products; blood products and related substances; in vitro diagnostics; and vaccines and related substances.