Technical standards and specifications
The WHO normative and standards setting work in the area of medicines, biologicals, blood and other products of human origin has served Member States for 75 years since the establishment of the WHO Constitution.
Biological and pharmaceutical standards
WHO issues international standards and guidance as adopted by Expert Committees. These norms and standards are important for facilitating production and registration of medicines; establishing the basis for the WHO prequalification process; promoting competition of generics and biosimilars; and contributing to the availability and affordability of quality medicines.
Blood and products of human origin
WHO develops norms, standards, technical guidance and high-level strategic recommendations and provides scientific assessment of current and emerging threats on ensuring availability, safety and quality of blood products and works to improve global access to transplantation of human organs and tissues. The work supports strengthening of country and regional capacity for the supply of quality-assured safe blood products and transplant services improving access to these life-saving treatments.
Events
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Expert committees
Technical reports
Publications
All →Guidance on implementing patient blood management to improve global blood health status
Incorporating expertise from peers working in countries where health care faces extreme resource constraints, attention is paid to how PBM processes...
Implementing cross-border transfer of domestic plasma to obtain plasma-derived medicinal products: policy...
The document provides recommendations on legal, regulatory and policy conditions for assuring the quality of plasma for fractionation and protecting the...
This document provides guidance on the activities needed to implement a functioning quality system in the BE, withinformation on the technical resources...
User guide for navigating resources on stepwise implementation of haemovigilance systems
WHO recognizes the importance of haemovigilance, systematic blood safety surveillance, to identify and prevent occurrence or recurrence of transfusion-related...
Action framework to advance universal access to safe, effective and quality-assured blood products 2020–2023
In response to calls for action, WHO has provided guidelines, physical standards, training and technical support to improve blood product quality, safety...