The assessment criteria for national blood regulatory systems were adopted by
the WHO Expert Committee on Biological Standardization at its sixty-second meeting, held
in Geneva from 17 to 21 October 2011. The document contains the collective views of the
WHO Blood Regulators Network. It was developed in response to a request from WHO and
the International Conference of Drug Regulatory Authorities for an assessment tool
to assist capacity building of national regulatory authorities for the regulation of blood
and blood products.
The tool is intended to help Member States to identify gaps and priorities
when developing capacity building programmes, and support the introduction of regulation of
blood products. Establishment of such regulation was recommended in the 2010 World Health
Assembly resolution (WHA63.12) on the availability, quality and safety of blood products.