Role of regulatory agencies |
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| Authors: | Jay Epstein Rainer Seitz Neelam Dhingra Peter R. Ganz Ahmad Gharehbaghian Renato Spindel Diana Teo Ravi Reddy |
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| Affiliation: | 1. Food and Drug Administration, Rockville, MD, USA;2. Paul-Ehrlich-Institut, Langen, Germany;3. WHO Headquarters, Geneva, Switzerland;4. Centre for Biologics Evaluation, Health Canada, Ottawa, Ontario, Canada;5. Iranian Blood Transfusion Organization (IBTO) Research Center, Tehran, Iran;6. Gerencia Geral de Sangue, Outros Tecidos, Células e Órgãos (GGSTO)/Agência Nacional Vigilância Sanitária (ANVISA), Brazil;7. Health Sciences Authority, Republic of Singapore;8. South African National Blood Transfusion Service, Cape Town, South Africa |
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| Abstract: | 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. |
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