53rd report: WHO TRS N°926: 2003

Overview

The WHO Expert Committee on Biological Standardization met in Geneva from 17 to 21 February 2003. Dr Asamoa-Baah, Executive Director of the Health Technology and Pharmaceuticals cluster at WHO, opened the meeting on behalf of the Director-General.

Dr Asamoa-Baah recalled the history of high scientific standards set at previous meetings of the Committee and paid tribute to Dr Elwyn Griffiths, the former Chief of the biologicals programme who had recently retired. He reminded the Committee that the written guidance and reference preparations established in accordance with their recommendations define international technical specifications for the quality and safety of biological medicines and in vitro diagnostic procedures. This work contributes to global public health in a fundamental way. WHO is also recognized as a standard-setting body in public health by the World Trade Organization (WTO) which means that standards established by WHO may be recognized by WTO as the basis for discussion and resolution of trade disputes. In considering the heavy agenda, Dr Asamoa-Baah noted that it reflected once again the increasing complexity and growth of the biologicals field. He highlighted the requests for updating recommendations for smallpox vaccine received from a number of countries, and the items concerning poliomyelitis, a disease that WHO had set as a priority for eradication by 2005. With regard to reference materials, he also drew attention to the need for a debate on the role of physical and chemical approaches to characterizations and potency assignment to biologicals. During the meeting, a number of proposals for reference materials for diagnostic testing, especially of blood, and needs in relation to transmissible spongiform encephalopathies were to be considered.