WHO Expert Committee on Biological Standardization. Sixty-seventh report

Overview

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 revision of WHO Guidelines for a number of vaccines, blood products and related substances. Specific discussion areas included WHO guidance on the production and evaluation of the quality, safety and efficacy of monoclonal antibodies as similar biotherapeutic products (SBPs); blood and blood components as essential medicines; estimation of residual risk of HIV, HBV or HCV infections via cellular blood components and plasma; snake antivenom immunoglobulins; human pandemic influenza vaccines in non-vaccine-producing countries; and clinical evaluation of vaccines: regulatory expectations. In addition, the following WHO guidance documents were also adopted: WHO manual for the preparation of secondary reference materials for in vitro diagnostic assays designed for infectious disease nucleic acid or antigen detection: calibration to WHO International Standards; and Human challenge trials for vaccine development: regulatory considerations. One WHO addendum document – Labelling information of inactivated influenza vaccines for use in pregnant women – was also adopted.

Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: biotherapeutics other than blood products; blood products and related substances; cellular and gene therapies; 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 nine WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2–10). Finally, all additions and discontinuations made during the 2016 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 11.

SPECIFIC REFERENCE FOR SNAKEBITES
Please refer to the ANNEX 5 : Guidelines for the production, control and regulation of snake antivenom immunoglobulins. Replacement of Annex 2 of WHO Technical Report Series, No. 964