WHO Expert Committee on Biological Standardization: Sixty-fifth Report [Pehme köide]

This report summarizes the recommendations of the World Health Organization Expert Committee on Biological Standardization, which met in Geneva, Switzerland, in October 2014 and was commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances, and the establishment of international biological reference materials on antibiotics, biotherapeutics, blood products and related substances, in vitro diagnostic device reagents, and vaccines and related substances. It summarizes reports from committee members on general aspects, including the activities of the Blood Regulators Network and collaborating centers, feedback from custodian laboratories, and the activities of other WHO committees and groups, then international recommendations, guidelines, and other issues, and reference materials on each type of substance, ending with a list of all documents, WHO documents adopted on the advice of the Committee, and a list of changes to WHO International Standards, Reference Reagents and Reference Panels for biological substances. Annotation ©2016 Ringgold, Inc., Portland, OR (protoview.com)

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 biological substances, 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 and adoption of new and revised WHO Recommendations, Guidelines and guidance documents. Following these discussions, a WHO guidance document on the Scientific principles for regulatory risk evaluation on finding an adventitious agent in a marketed vaccine was adopted along with WHO Guidelines on procedures and data requirements for changes to approved vaccines and revised WHO Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated).

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 three WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2 4). Finally, all additions and discontinuations made during the 2014 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 5.