WHO Expert Committee on Biological Standardization

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.

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 Recommendations to assure the quality, safety and efficacy of recombinant hepatitis E vaccines; WHO Guidelines for the safe development and production of vaccines to human pandemic influenza viruses and influenza viruses with pandemic potential; and WHO Guidelines for the safe production and quality control of poliomyelitis vaccines were adopted on the recommendation of the Committee. In addition, a WHO questions-and-answers guidance document on the evaluation of similar biotherapeutic product (SBPs) was also adopted with the Committee recommending that it be posted on the WHO website.

Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: antibiotics; blood products and related substances; cellular and gene therapies; in vitro diagnostics; standards for use in public health emergencies; 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 three WHO documents adopted for publication on the advice of the Committee are then presented as part of this report (Annexes 2-4). Finally, all additions and discontinuations made during the 2018 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 5. The updated full catalog of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en