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, tobacco, blood tissues and organs, cellular therapies, sanitizing products, and other health products and services. ANVISA was created by Federal Law 9.782 in 1999. ANVISA’s mission is to protect and promote the health of the population, intervening the risks associated with production and use of products and services subject to health regulation, in a coordinated and integrated action within the National Health System (SUS), as well as public health control of airports, customs and borders.
With respect to the regulation of cellular therapies, ANVISA periodically updates a specific regulation (currently RDC 214 of February 7, 2018) 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.
Via a federal regulation (currently RDC 214 of February 7, 2018), 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 types of cord blood banks. The first is designated for establishments engaged in activities for unrelated and related allogeneic use of HPC from bone marrow, peripheral blood and Cord Blood, and they are members of the BrazilCord Network. The second category is designated for establishments engaged in working with HPC, Cord Blood for related allogeneic and autologous use. Cord blood banks are required to maintain an up to date license to operate issued by a state or municipal-level health agency.
The technical standard requirements for the operation of public and private Cellular Processing Centers (Centros de Processamento Celular or CPCs) that perform clinical research and therapy also have been established via the same regulation RDC 214 of February 7, 2018. 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 therapy, research, training, quality control and process validation. 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.
The minimum regulatory requirements for the operation of reproductive tissue/cell banks have been established by ANVISA through regulation RDC Nº 23, of May 27, 2011. 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, storage, quality control, and release.
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