70th report: WHO TRS N°1024: 2019

Overview

The WHO Expert Committee on Biological Standardization met in Geneva from 21 to 25 October 2019. The meeting was opened on behalf of the DirectorGeneral of WHO by Dr Mariângela Batista Galvão Simão, Assistant DirectorGeneral, Access to Medicines and Health Products. Dr Simão welcomed the Committee, meeting participants and observers. 

Dr Simão noted how the new global agenda, as articulated in the sustainable development goals, places a strong emphasis on equity and human rights in health. This provides WHO, and in particular the WHO Department of Essential Medicines and Health Products, with an opportunity to build upon the progress made to bring about access to quality essential medicines and health products for all. 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 respiratory syncytial virus vaccines; and an Amendment document to the WHO Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated) were adopted on the recommendation of the Committee. 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; cellular and gene therapies; in vitro diagnostics; and vaccines and related substances.