WHO Expert Committee on Biological Standardization. Sixty-eighth report

Overview

The WHO Expert Committee on Biological Standardization met in Geneva from 17 to 20 October 2017. The meeting was opened on behalf of the DirectorGeneral of WHO by Dr Suzanne Hill, Director of Essential Medicines and Health Products (EMP) and currently Acting Assistant Director-General for the Health Systems and Innovations Cluster. 

Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development and adoption of new and revised WHO Recommendations, Guidelines and guidance documents. Following these discussions, 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 selftesting; 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. A series of annexes are then presented which include an updated list of all WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1). The above four WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2–5). Finally, all additions and discontinuations made during the 2017 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 6.