Similar to the United States Food and Drug Administration, the Agência Nacional de Vigilância Sanitária (ANVISA) is the authority in Brazil that is responsible for the regulatory oversight of a variety of health products and services. ANVISA's oversight includes food, cosmetics, drugs, laboratories, tobacco, blood and blood products, cellular therapies, sanitizing products, and other health services. Created by Federal Law 9.782 in 1999, it is charged with protecting and promoting health, ensuring the quality and safety of products and services, and taking part in developing access to health products in Brazil.
With respect to the regulation of cellular therapies, ANVISA has established several regulations to ensure product quality, and patient and donor safety, which includes the development of standards and technical requirements, inspection of laboratories and services, and monitoring adverse events. Within ANVISA, the General Office of Blood, Other Tissue, Cells, and Organs is responsible for regulation of cellular therapies. While many cellular therapy-related activities and services are handled at the national level, surveillance and inspections of facilities and laboratories are regulated at the state and municipal levels, which are subject to specific ordinances and regulations. Brief summaries and highlights of cellular therapy-related legislation and regulations are provided below.
Hematopoietic Progenitor Cells
Via a federal resolution, ANVISA has established technical standards for the operation of facilities engaged in the collection, processing, cryopreservation, storage, quality control, laboratory testing, and transport of hematopoietic progenitor cells (HPC) sourced from bone marrow, peripheral blood, and placental/umbilical cord blood, and intended for human transplantation. Specific technical standard requirements for the following topics are covered: human resources, quality assurance, biosecurity, in vitro use reagents and diagnostics, equipment, physical infrastructure, donor selection, collection, processing, labeling and storage, release and distribution, transport conditions, and registry information. These technical standards apply equally to public and private cord blood banks. It is important to know the intended use/recipient – related or unrelated allogeneic, or autologous – of the cord blood before collection because the specific requirements for donor qualification and processing are different. These differences are specified in the federal resolution.
ANVISA also has established two different cord blood bank networks. The first network is designated for establishments engaged in activities for unrelated and related allogeneic HPC, Cord Blood and is also referred to as the Banco de Sangue de Cordão Umbilical e Placentário para uso Alogênico (BSCUP) and the BrazilCord Network. The second category is designated for establishments engaged in working with HPC, Cord Blood for autologous use, and the network is commonly referred to as the Banco de Sangue de Cordão Umbilical e Placentário para uso Autólogo (BSCUPA). Banks working in the BSCUP network must operate as public entities and banks handling autologous products within the BSCUPA network must operate as private entities. Cord blood banks are required to possess a license from a state or municipal-level health agency, and certain cord blood banks must obtain an operating permit in accordance with relevant ordinances.
Cellular Technology Centers
The technical standard requirements for the operation of public and private Cellular Technology Centers (Centros de Tecnologia Celular or CTCs) that perform clinical research and therapy also have been established via resolution. The requirements cover the following activities: collection, processing, packaging, storage, testing, quality control, disposal, transport, and release of cellular therapy products. These requirements are intended to ensure the safety and quality of cells and their derivatives made available for clinical research and therapy. Specifically, the resolution also establishes technical provisions, which include, but are not limited to, information regarding technical operations manual, quality assurance, biosafety, equipment, and donor and patient selection.
Reproductive Cell and Tissue Banks
The minimum regulatory requirements for the operation of reproductive cell and tissue banks have been established by ANVISA through a resolution. These technical standards and operating criteria cover selection of the donor and patient, infrastructure and environmental conditions of the facility, and provisions for collection, processing, quality control, and release.