This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of
vaccines and other
biologicals, and the establishment of international
biological reference materials. 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 of revised WHO Recommendations and Guidelines for a number of
vaccines, blood products and related substances. Specific discussion areas included the development of WHO guidance on the quality, safety and efficacy of
poliomyelitis vaccines; recombinant malaria vaccines;
diphtheria vaccines;
tetanus vaccines; combined vaccines based on
diphtheria and
tetanus vaccines; and
Japanese encephalitis vaccines. Subsequent sections of the report then provide information on the current status and proposed development of international reference materials in the areas of
vaccines and related substances; blood products and related substances;
in vitro diagnostic device reagents; biotherapeutics other than blood products; and
antibiotics. A series of annexes are then presented which include an updated list of WHO Recommendations, Guidelines and other documents on
biological substances used in medicine (Annex 1), followed by a series of WHO Recommendations and Guidelines adopted on the advice of the Committee (Annexes 2-7). All additions made during the meeting to the list of International Standards and Reference
Reagents for
biological substances maintained by WHO are then summarized in Annex 8, and are also available at: http://www. who.int/
biologicals.