Assessment Criteria for National Blood Regulatory Systems. WHO Expert Committee on Biological Standardization, Sixty-second Report; WHO Technical Report Series No. 979, 2013, Annex 7
(2013; 48 pages)


The following 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 17–21 October 2011. This annex reflects the collective views of the WHO Blood Regulators Network, and was developed in response to a request from WHO and the International Conference of Drug Regulatory Authorities for an assessment tool to support NRA capacity-building in relation to the regulation of blood and blood products. The tool is intended to help WHO Member States identify gaps and priorities when developing capacity-building programmes, and to support the introduction of regulation of blood products. The establishment of such regulation was recommended in the 2010 World Health Assembly resolution WHA63.12 on the availability, quality and safety of blood products.

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