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.