- Palabras clave > biological standardization
- Palabras clave > blood and blood products - capacity building of national regulatory systems
- Palabras clave > blood establishments
- Palabras clave > blood products
- Palabras clave > blood products and related biologicals - quality assurance and safety
- Palabras clave > Good Manufacturing Practices - blood establishment
- Palabras clave > national blood regulatory systems
- Palabras clave > national or regional blood regulatory system
- Palabras clave > national regulatory systems - assessment
(2012; 40 pages)
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.