title: [Blood regulation in Brazil: contextualization for improvement].
abstract: The use of blood products as essential medicines and the recognition of the high risk associated with blood transfusions require governments to take regulatory action with a focus on quality and safety. In this scenario, regulatory agencies play an essential role in socially advancing the guarantee that blood components will be produced according to current operating rules. Thus, in the effort to manage sanitary risks involved in the processing and use of blood, the Brazilian regulatory model, based on the construction of a national blood policy overseen by the State, has undergone conceptual improvement and review of the tools employed to achieve its goals. With the inclusion of good manufacturing practices as part of the Brazilian norms, as recommended by the World Health Organization, the country has moved forward in its view of blood facilities as manufacturing centers producing blood-derived biologics for therapeutic applications. It has also strengthened the need to develop safety mechanisms for blood donors and recipients. The development of a State-coordinated national blood policy and the institution of a national surveillance system with legitimate power of inspection are essential elements used in Brazil to guarantee the amount, quality, safety, and timeliness of blood supply to the population. The present article aims to discuss the present context of the blood regulatory model in Brazil so as to identify the challenges for improvement of this model.
authors.affiliation: Agência Nacional de Vigilância Sanitária, Brasília, DF, Brasil, batista.junior@anvisa.gov.br.
authors.forename: João Batista
authors.initials: JB
authors.lastname: Silva Júnior
authors.affiliation: Agência Nacional de Vigilância Sanitária, Brasília, DF, Brasil, batista.junior@anvisa.gov.br.
authors.forename: Christiane da Silva
authors.initials: Cda S
authors.lastname: Costa
authors.affiliation: Ministério da Saúde, Coordenação Geral de Sangue e Hemoderivados, Brasília, DF, Brasil.
authors.forename: João Paulo de Araújo
authors.initials: JP
authors.lastname: Baccara
mesh_terms: D001800:Blood Specimen Collection; D001938:Brazil; D014944:World Health Organization