WHO Expert Committee on Biological Standardization: eightieth report

World Health Organization

2025년 6월 · World Health Organization

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This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international WHO Recommendations, Guidelines and other documents related to the manufacture, quality control and evaluation of biological products used in medicine, and to the establishment of WHO international reference standards for such products. Following a brief introduction, the report summarizes a number of issues brought to the attention of the Committee at its meeting held in hybrid format in October 2024. Of particular relevance to manufacturers and national regulatory authorities is the adoption of the following three documents by the Committee: (a) Recommendations to assure the quality, safety and efficacy of rotavirus vaccines; (b) Nonclinical and clinical evaluation of monoclonal antibodies and related products intended for the prevention of respiratory syncytial virus disease; and (c) Good practices for blood establishments. A series of annexes is then presented which includes an updated list of all WHO Recommendations, Guidelines and other documents related to the manufacture, quality control and evaluation of biological products (Annex 1). The above three WHO documents adopted on the advice of the Committee are then presented as part of this report (Annexes 2–4). Finally, all WHO international reference standards for biological products recommended for establishment or discontinuation during the meeting are summarized in Annex 5.