Role of regulatory agencies Jay Epstein a, * , Rainer Seitz b , Neelam Dhingra c , Peter R. Ganz d , Ahmad Gharehbaghian e , Renato Spindel f , Diana Teo g , Ravi Reddy h a Food and Drug Administration, Rockville, MD, USA b Paul-Ehrlich-Institut, Langen, Germany c WHO Headquarters, Geneva, Switzerland d Centre for Biologics Evaluation, Health Canada, Ottawa, Ontario, Canada e Iranian Blood Transfusion Organization (IBTO) Research Center, Tehran, Iran f Gerencia Geral de Sangue, Outros Tecidos, Ce ´lulas e O ´ rg~ aos (GGSTO)/Age ˆncia Nacional Vigila ˆ ncia Sanita ´ria (ANVISA), Brazil g Health Sciences Authority, Republic of Singapore h South African National Blood Transfusion Service, Cape Town, South Africa Received 9 January 2009; accepted 9 January 2009 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. Published by Elsevier Ltd on behalf of The International Association for Biologicals. Keywords: Blood regulation; WHO; Reform; Public health 1. Introduction Dr. Jay Epstein (jay.epstein@fda.hhs.gov) A safe and adequate blood supply is essential to modern medicine, but has yet to be achieved in all countries. In any region, meeting the goal of universal access to safe blood transfusion requires a highly integrated system including recruitment of suitable donors; performance of infectious disease and blood group compatibility tests; preparation and storage of blood products according to established quality standards; effective distribution systems; and appropriate clinical use. Experience in many countries has taught us that a successful blood program depends upon nationally coordinated blood services which operate under the effective oversight of a legally empowered regulatory authority. In this paper, the authors provide a broad discussion of the national and international role of regulation in assuring blood safety. Selected examples of blood systems in several developed and developing countries and regions provide insight on the global variation in blood programs and their regulatory frameworks. Despite some differences in the approach, a clear pattern emerges of worldwide efforts to strengthen blood regulatory systems consistent with principles that have been articulated by the World Health Organization. 2. Safe blood: a regulator’s reflection and perspective Prof. Rainer Seitz (seira@pei.de) Blood products, i.e., both blood components for trans- fusion and plasma derivatives, are an essential element in * Corresponding author. E-mail address: jay.epstein@fda.hhs.gov (J. Epstein). 1045-1056/09/$36.00 Published by Elsevier Ltd on behalf of The International Association for Biologicals. doi:10.1016/j.biologicals.2009.01.004 Available online at www.sciencedirect.com Biologicals 37 (2009) 94e102 www.elsevier.com/locate/biologicals