Role of regulatory agencies.
In this paper the authors discuss the role of regulation in assuring blood safety. After an overview of the subject by a leading expert, examples are provided of regulatory systems for blood transfusion services in several countries and regions. Additionally, the perspective of WHO is given on the essential role of national regulatory authorities in assuring the quality of national blood programmes. Collectively, the sections of this paper afford an opportunity for readers to make comparisons among different regulatory frameworks and to "benchmark" among the existing systems. Despite many differences in approach, a clear pattern emerges of worldwide efforts to strengthen blood regulatory systems.
Epstein
Jay
J
Food and Drug Administration, Rockville, MD, USA. jay.epstein@fda.hhs.gov
Seitz
Rainer
R
Dhingra
Neelam
N
Ganz
Peter R
PR
Gharehbaghian
Ahmad
A
Spindel
Renato
R
Teo
Diana
D
Reddy
Ravi
R
D000349:Africa; D001210:Asia, Southeastern; D001803:Blood Transfusion / Q000331:legislation & jurisprudence*; D001938:Brazil; D002170:Canada; D033161:Government Regulation; D006801:Humans; D007390:International Agencies / Q000331:legislation & jurisprudence; D007492:Iran; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence*; D012449:Safety; D065227:Transfusion Reaction; D014944:World Health Organization