WHO Expert Committee on Biological Standardization. Sixty-sixth report

Overview

The WHO Expert Committee on Biological Standardization met in Geneva from 12 to 16 October 2015. The meeting was opened by Mr Kees De Joncheere, Director of the Department of Essential Medicines and Health Products (EMP). The inclusive standards development process implemented by WHO facilitates global consensus on technical matters and is a very significant factor in promoting convergent regulatory decision-making between countries. After standards have been established, proactive technical support from WHO was crucial in obtaining maximum understanding and impact, and facilitating the consistent application of standards.

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, a WHO guidance document on Regulatory assessment of approved rDNA-derived biotherapeutics was adopted along with WHO Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions and on WHO good manufacturing practices for biological products. In addition, revised WHO Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines were also adopted by the Committee.

Subsequent sections of the report provide information on the current status and proposed development of international reference materials in the areas of antibiotics; biotherapeutics other than blood products; blood products and related substances; in vitro diagnostic device reagents; 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 four WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2–5). Finally, all additions and discontinuations made during the 2015 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 6.