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WHO Expert Committee on Biological Standardization: Sixty-Eighth Report (WHO Technical Report Series, No This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the 1011 adoption of international recommendations for the production WHO Technical Report Series and control of vaccines and other biological substances, and the establishment of international biological reference materials. 1011 Following a brief introduction, the report summarizes a number WHO of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers Expert on Biological Standardization Committee 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, WHO Guidelines on the quality, safety and efficacy of Ebola vaccines, and WHO Guidelines on procedures and data requirements for changes to approved biotherapeutic products were adopted on the recommendation of the Committee. In addition, the following two WHO guidance documents on the WHO prequalification of in vitro diagnostic medical devices were also adopted: (a) Technical Specifications Series (TSS) for WHO Prequalification – WHO Expert Committee Diagnostic Assessment: Human immunodeficiency virus (HIV) rapid diagnostic tests for professional use and/or self- on Biological testing; and (b) Technical Guidance Series (TGS) for WHO Prequalification – Diagnostic Assessment: Establishing stability of in vitro diagnostic medical devices. Standardization Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: antibiotics, biotherapeutics other than blood products; blood products Sixty-eighth report and related substances; in vitro diagnostics; and vaccines and related substances. A series of annexes are then presented which include an WHO updated list of all WHO Recommendations, Guidelines and other documents on biological substances used in medicine Technical Report Series Technical (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 2017 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 6. The updated full catalogue of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/. ISBN 978 92 4 121020 1 SELECTED WHO PUBLICATIONS OF RELATED INTEREST WHO Expert Committee on Biological Standardization The World Health Organization was established in 1948 as a specialized agency of the Sixty-seventh report. United Nations serving as the directing and coordinating authority for international WHO Technical Report Series, No. 1004, 2017 (xviii + 591 pages) health matters and public health. One of WHO’s constitutional functions is to provide objective and reliable information and advice in the field of human health, WHO Expert Committee on Biological Standardization a responsibility that it fulfils in part through its extensive programme of publications Sixty-sixth report. WHO Technical Report Series, No. 999, 2016 (xix + 267 pages) The Organization seeks through its publications to support national health strategies and address the most pressing public health concerns of populations around the world. WHO Expert Committee on Biological Standardization To respond to the needs of Member States at all levels of development, WHO publishes Sixty-fifth report. practical manuals, handbooks and training material for specific categories of health WHO Technical Report Series, No. 993, 2015 (xvi + 262 pages) workers; internationally applicable guidelines and standards; reviews and analyses of health policies, programmes and research; and state-of-the-art consensus reports that WHO Expert Committee on Biological Standardization offer technical advice and recommendations for decision-makers. These books are Sixty-fourth report. closely tied to the Organization’s priority activities, encompassing disease prevention WHO Technical Report Series, No. 987, 2014 (xviii + 266 pages) and control, the development of equitable health systems based on primary health care, and health promotion for individuals and communities. Progress towards better WHO Expert Committee on Biological Standardization health for all also demands the global dissemination and exchange of information Sixty-third report. that draws on the knowledge and experience of all WHO’s Member countries and the WHO Technical Report Series, No. 980, 2014 (xv + 489 pages) collaboration of world leaders in public health and the biomedical sciences. WHO Expert Committee on Biological Standardization To ensure the widest possible availability of authoritative information and guidance on Sixty-second report. health matters, WHO secures the broad international distribution of its publications WHO Technical Report Series, No. 979, 2013 (xiii + 366 pages) and encourages their translation and adaptation. By helping to promote and protect WHO Expert Committee on Biological Standardization health and prevent and control disease throughout the world, WHO’s books contribute Sixty-first report. to achieving the Organization’s principal objective – the attainment by all people of the WHO Technical Report Series, No. 978, 2013 (xi + 384 pages) highest possible level of health. WHO Expert Committee on Biological Standardization The WHO Technical Report Series makes available the findings of various international Sixtieth report. groups of experts that provide WHO with the latest scientific and technical advice on WHO Technical Report Series, No. 977, 2013 (viii + 231 pages) a broad range of medical and public health subjects. Members of such expert groups serve without remuneration in their personal capacities rather than as representatives WHO Expert Committee on Biological Standardization of governments or other bodies; their views do not necessarily reflect the decisions or Fifty-ninth report. the stated policy of WHO. WHO Technical Report Series, No. 964, 2012 (viii + 228 pages) For further information, please contact: WHO Press, World Health Organization, 20 Website: http://www.who.int/biologicals avenue Appia, 1211 Geneva 27, Switzerland (tel. +41 22 791 3264; fax: +41 22 791 4857; email: [email protected]; order on line: www.who.int/bookorders). Further information on these and other WHO publications can be obtained from WHO Press, World Health Organization, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: + 41 22 791 4857; email: [email protected]; order online: www.who.int/bookorders) WHO Technical Report Series 101 1 WHO Expert Committee on Biological Standardization Sixty-eighth report This report contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the World Health Organization WHO Expert Committee on Biological Standardization: sixty-eighth report (WHO Technical Report Series, No. 1011) ISBN 978-92-4-121020-1 ISSN 0512-3054 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial- ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/ igo). 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WHO Expert Committee on Biological Standardization: sixty-eighth report. Geneva: World Health Organization; 2018 (WHO Technical Report Series, No. 1011). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/ about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. 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