World Health Organ Tech Rep Ser. 2013(977):1-231, back cover.
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. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains revised WHO Recommendations for production and control of live attenuated influenza vaccines and for production and control of pneumococcal conjugate vaccines. New WHO Guidelines on the regulatory evaluation of similar biotherapeutic medicines are also provided. Also included are a list of Recommendations, Guidelines and other documents for biological substances used in medicine, and of International Standards and Reference Reagent for biological substances.
本报告介绍了世界卫生组织一个专家委员会的建议，该委员会受委托协调各项活动，以推动通过有关疫苗及其他生物制品生产与控制的国际建议，并建立国际生物参考物质。报告开篇讨论了引起委员会关注的一般性问题，并提供了各类抗体、抗原、血液制品及相关物质、细胞因子、生长因子、内分泌物质和体外诊断装置参考物质的现状与发展信息。报告的第二部分对制造商和国家监管当局尤为重要，其中包含世界卫生组织关于减毒活流感疫苗生产与控制以及肺炎球菌结合疫苗生产与控制的修订建议。还提供了世界卫生组织关于相似生物治疗药物监管评估的新指南。此外，还列出了用于医学的生物物质的建议、指南及其他文件清单，以及生物物质的国际标准和参考试剂清单。
