This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations to assure the quality, safety and efficacy of vaccines, blood products and other biological medicines, and the establishment of international biological reference standards.
The report starts with a discussion of general issues brought to the Committee's attention and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains WHO recommendations and guidelines on human papillomavirus vaccines; meningococcal A conjugate vaccines; and stability evaluation of vaccines.
Also included are a list of recommendations, guidelines and other documents for biological substances used in medicines, and of international standards and reference reagent for biological substances.
About the Author
World Health Organization is a Specialized Agency of the United Nations, charged to act as the world's directing and coordinating authority on questions of human health. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.