WHO Expert Committee on Biological Standardization. Sixty-ninth report

Overview

The WHO Expert Committee on Biological Standardization met in Geneva from 29 October to 2 November 2018. The meeting was opened on behalf of the Director-General of WHO by Dr Soumya Swaminathan, Deputy DirectorGeneral for Programmes. Dr Swaminathan welcomed the Committee, meeting participants and observers, and reminded them that this was the longest serving WHO expert committee and was very much valued by WHO for its contribution to global public health over many years.

It was further recognized that recent years had seen a rapid expansion of the biologicals field, leading to the development of novel biotherapeutic products, vaccines, cellular therapies and in vitro diagnostics (IVDs). This had resulted in an ever greater demand for biological standardization efforts. 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.