ANVISA Research Articles

ENVIRONMENTAL MANAGEMENT: CHALLENGES AND SOLUTIONS IN THE SEGREGATION OF HEALTHCARE WASTE IN BELÉM

Healthcare waste (HSW) refers to materials resulting from healthcare activities, both human and animal, which may present biological, chemical or radiological risks, depending on their nature. This study aimed to investigate the effectiveness of healthcare waste segregation in the city of Belém, based on the evaluation of two large hospitals in the city; seeking to identify and mitigate the non-conformities observed in relation to current regulations, as well as to propose solutions. This is a cross-sectional, descriptive and exploratory research, with a quantitative and qualitative approach, carried out at the Ophir Loyola and Mário Pinotti hospitals, in the city of Belém. The investigation highlighted significant failures in the separation and management of waste in several sectors of these units, compromising environmental safety and the effectiveness of public policies. The analysis was guided by the regulations of Resolution RDC No. 222/2018, of the National Health Surveillance Agency (Anvisa), and Resolution No. 358/2005, of the National Environmental Council (CONAMA). The results indicate the existence of structural and operational gaps that hinder compliance with regulatory guidelines, revealing the need for urgent corrective measures to ensure efficient and safe management of HCW. The research highlights the importance of strengthening team training, improving segregation processes and encouraging the implementation of sustainable practices, thus ensuring the protection of public health and the environment.

Borrowing Regulatory Capacity in Middle-Income Countries during Public Health Crises: Brazil, Regulatory Reliance, and the Politics of COVD-19 Vaccine Regulation

The COVID-19 pandemic underscored the critical role of states’ regulatory capacities. Countries had to authorize novel vaccine technologies in the context of scientific uncertainty and political pressure, issues particularly acute in middle-income countries (MICs) less familiar with the procedures needed to streamline regulatory processes during a crisis. How did regulatory agencies in countries still building their regulatory capacities expedite the authorization of new COVID-19 vaccines to combat the pandemic? How did they navigate political pressures to expedite vaccine approval while maintaining safety and efficacy standards? We explore these questions through the case of Brazil, which has one of Latin America’s most highly-regarded regulatory authorities, but was subject to acute political conflicts. In response to these tensions, the Brazilian National Health Surveillance Agency (Anvisa) leveraged “regulatory reliance” to expedite the authorization of COVID-19 vaccines. Regulatory reliance, the practice of relying on the decisions and procedures of external advanced regulatory agencies, allowed Anvisa to bolster its internal capacity and navigate domestic political challenges. This paper highlights the dual benefits of regulatory reliance: enhancing regulatory efficiency during crises and mitigating politicization pressures. The findings demonstrate that MICs can better respond to public health emergencies by integrating external expertise, thus contributing to global regulatory resilience. In addition, the implications extend to broader regulatory political economy discussions, suggesting that reliance mechanisms can fortify less mature regulatory systems and promote convergence even in the absence of global harmonization.

Validation of chromatographic methods, TLC and HPLC, to quantify known radiochemical impurities and the radiochemical purity the radiopharmaceutical [177Lu]Lu-PSMA I&T

The Energy and Nuclear Research Institute (IPEN) is studying the production of the radiopharmaceutical [177Lu]Lu-PSMA I&T, in accordance with the good manufacturing practices recommended by the National Health Surveillance Agency (ANVISA), to be used in the therapy of prostate cancer. This work aims to validate chromatographic methods, Thin-Layer Chromatographic (TLC) and high-performance liquid chromatography (HPLC), to determine the radiochemical purity (RCP) of the product. The entire validation process of this work was based on ANVISA's RDC 166, 2017 and the Guide 10, version 1, 2017, guided the statistical treatments adopted. With the selectivity study we can observe that the presence of impurities or excess excipients in the sample does not interfere with the quantification of the product. The proposed methods were linear with linear correlation coefficients (r) above 0.99. The precision and repeatability presented relative standard deviation values lower than specified (RSD <5 %). The small controlled variations in the method suggested for the robustness test also did not affect the radiochemical purity of the product. In view of the results and in accordance with the criteria established by the National Health Surveillance Agency (ANVISA), the two chromatographic methods were validated in accordance with RDC 166, 2017, proving to be selective, precise, linear and robust. The validation of TLC and HPLC methods enables their application in the batch release routine of the new radiopharmaceutical at Radiopharmacy Center of IPEN.

Search for Listeria spp. in fresh type sausages sold in the agreste region of Pernambuco and its importance for public health

Foodborne diseases (FBDs) are considered illnesses related to the ingestion of foods contaminated with physical, chemical, or pathogenic microorganisms. The genus Listeria spp. is responsible for the foodborne illness listeriosis. This pathology poses a significant public health risk due to its high mortality and sequelae, particularly affecting immunocompromised patients, pregnant women, the elderly, and children. The purpose of this study was to evaluate the presence of Listeria spp. in commercial fresh sausages. Eighteen samples of raw fresh sausages were collected and divided into three portions. Some were subjected to thermal treatments at two different temperatures (55ºC and 74ºC), while another portion remained raw, totaling 54 samples. Listeria monocytogenes and Listeria spp. research and isolation were conducted according to ISO 11290-1:2017. Biochemical tests were performed using the Gram staining methodology on characteristic strains. Additionally, moisture and ash determination and statistical analysis of the results were conducted. Among the 54 samples analyzed, approximately eight isolates showed colonies with characteristics suggestive of Listeria spp., thus not complying with the microbiological standards established by Resolution of the Collegiate Board (RDC) 331/2019 of the National Health Surveillance Agency (ANVISA). The presence of L. innocua and other pathogenic bacterial species in the samples is concerning, as there is a likelihood of microorganisms proliferating in the equipment and utensils used in sausage preparation, thus spreading pathogens to other products and increasing the risk of foodborne outbreaks and infections.

Index of application status transparency and availability of public information for Project Orbis agencies

The purpose of this paper is to provide a guideline for understanding and comparing the regulatory framework of Project Orbis Partners (POPs) and Project Orbis observers, with a focus on their approaches to drug approvals, rejections, and withdrawals. While each agency has its own regulatory framework and guidance, there are some similarities and differences between the language used to describe drug approvals, rejections, withdrawals, and the public availability of these decisions. Project Orbis is an international partnership of regulatory agency, led by the U.S. Food and Drug Administration (FDA), aimed at streamlining the submission and review processes to expedite the global availability of oncology medications for patients. Since its inception, Australia’s Therapeutic Goods Administration (TGA), Brazil’s National Health Surveillance Agency (ANVISA), Canada’s Health Canada (HC), Israel’s Ministry of Health (IMoH) Medical Technologies, Health Information, Innovation and Research (MTIIR) Directorate, Singapore’s Health Sciences Authority (HSA), Switzerland’s Swissmedic (SMC), and United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) have joined and become POPs. Other international agencies such as, the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are currently observing Project Orbis, as of late 2023. They are not full Project Orbis partners but work closely with the FDA to facilitate oncology drug approval through international collaboration. Running Title: An Index of the FDA and international regulators involved in Project Orbis looking at the similarities and differences between approval, rejection, and withdrawal characteristics of applications and public transparency of actions.

Autoimplantação de um Sistema de Gestão da Qualidade no Sistema Nacional de Vigilância Sanitária: análise da estratégia utilizada no Projeto Integravisa III

Introduction: The implementation of quality management systems (QMS) has been a strategy encouraged by the National Health Surveillance Agency (Anvisa) for bodies within the National Health Surveillance System. Objective: This article describes and analyzes a project to support the self-implementation of QMS in state Health Surveillance units (Visas). Method: Experience report, which considered the results of an online activity evaluation questionnaire, answered by Visas workers participating in the project, addressing, among other aspects, facilitating and hindering factors for the self- implementation process in the respective institutions, as a corpus of analysis. Results: The facilitators were teaching material, consultancy, support for self-implementation, and feedback on documents produced to meet the QMS requirements. The obstacles were the lack of structure, time, and maturity of some teams in dealing with the demands of self-implementation, the excess of work resulting from the overlapping of daily activities with the production of documents for quality management, as well as the absence felt by teams that required more faceto-face time with project consultants. Conclusions: The process brought gains to Visas, in general, but it was clear that for the effective continuation of the self-implementation process, commitment and dedication by managers and teams are necessary.

Evaluation of drug litigation against the Campinas municipal health system from 2017 to 2021

In Brazil, the judicialization of public health for access to medications has resulted in significant challenges to the management of public policies, especially at the municipal level. To evaluate the profile of drug litigations against the Campinas municipal health system from 2017 to 2021, this study analyzed the characteristics of litigants, medicine dispensation, and the timing of court decisions. A quantitative, analytical, and comparative cross-sectional study was conducted using data on the dispensation of 506 types of medications and 493 court cases. The analysis included sociodemographic, procedural, medical–sanitary, and pharmaceutical assistance management variables. The time of court decisions was assessed using the Kruskal‒Wallis test complemented by the Dunn test. The plaintiffs were predominantly adults, females, and self-declared students, and some cases involved nonresidents. Most of the lawsuits were represented by private lawyers, gratuitousness of justice and with decisions favorable to the plaintiff. However, only 43% of the patients obtained a preliminary injunction or early tutelage. The median time needed for a court decision from the date of case filing was 12 days until the granting of a preliminary injunction or early tutelage and 6.5 months until a judgment or dismissal without a decision on the merits. Approximately 32.4% of the medications dispensed by the judicial pharmacy already belonged to the list of the Brazil’s Unified Health System in 2020; 46.3% were prescribed by their generic name; 75.5% had therapeutic equivalents, and 94.9% had marketing authorization from the Brazilian National Health Surveillance Agency. Judicialization in Campinas is an alternative way of accessing medications, but it is time-consuming and benefits only a small portion of the population (0.068%). The characteristics of the plaintiffs and judicialized medicines highlight the need to review health policies to promote equitable and efficient access to essential treatments for the population.

Assessing antimicrobial stewardship governance in Northeast Brazilian hospitals: a survey-based analysis.

Effective governance of antimicrobial stewardship (AMS) and infection prevention control (IPC) in healthcare facilities is crucial for safeguarding patients against healthcare-associated infections and enhancing patient outcomes by optimizing antibiotic use and curbing the spread of antimicrobial-resistant (AMR) pathogens. To assess the current AMS governance in two public hospitals in Northeast of Brazil, specifically focusing on identifying institutional antibiotic policies and operational practices. A survey was conducted by team leaders of both hospitals from 2020 to 2022 using a questionnaire adapted from the Pan American Health Organization (PAHO) recommendations for implementing AMS programmes (ASP) in Latin America and the Caribbean, alongside criteria from the National Health Surveillance Agency (ANVISA) and CDC. Fifty leaders, from senior management to coordinators, answered the questionnaire. Results indicate a lack of AMS process measures, specialist support, systematic antimicrobial utilization analysis and structured IPC programmes, especially in one hospital where patient records remain in paper format. The empirical use of antimicrobials without local epidemiological or susceptibility data underscores the absence of logistical support for microbiological cultures in the region. These findings emphasize the urgent need for systematic AMS processes and multiprofessional teams to drive AMS and IPC practices, essential for patient care and safety.

Bioaccumulation of chemical elements in fish from areas affected by oil on the coast of Bahia, Brazil

In 2019, the Brazilian coast was affected by the largest oil spill in its history. We assessed the levels of chemical elements in Lutjanus synagris and Haemulon aurolienatum fish from Itacaré (least affected area), Tinharé-Boipeba (most affected area) and Madre de Deus (chronically affected area). The level of metals differed between species, tissues, life cycle phases, maturation stages and between sampled locations, indicating the influence of biological and environmental aspects on bioaccumulation. Only fish in Madre de Deus showed lead contamination, while arsenic concentrations in the three areas exceeded the maximum value acceptable by Anvisa (National Health Surveillance Agency). It is suggested that the oil spill may have impacted species differently, also having an impact in fish from less affected areas. However, metal concentrations in fish in Madre de Deus stood out when compared to populations in other studied areas.

Unmet need for and impact of adopting immunobiological drugs for moderate to severe plaque psoriasis in a pediatric population.

Therefore, this study aimed to evaluate the impact of secukinumab and ustekinumab against moderate-to-severe plaque psoriasis in a Brazilian pediatric population with access to public healthcare. A survey of immunobiological treatments registered for use against pediatric psoriasis at the National Health Surveillance Agency was conducted. These treatments were compared to the list available in the same treatment category in the public health system through the Clinical Protocol and Therapeutic Guidelines for psoriasis. A quantitative analysis of the data of patients treated with immunobiological drugs the previous year in accordance with the Clinical Protocol and Therapeutic Guidelines was performed using data available in the DATASUS portal. The public budget impact scenarios analyzed were comparable to the investment already planned for acquiring the only available drug option. The incorporation of two therapeutic options in the Clinical Protocol and Therapeutic Guidelines list for moderate-to-severe pediatric psoriasis was feasible in a horizon of 5 years compared to the investment into the single option available to pediatric patients. These findings can facilitate the local analysis of budgetary impact and discussions on the feasibility of this therapeutic incorporation at the state level. Incorporation of secukinumab and ustekinumab was economically feasible. These drugs are options for those who do not respond to or have contraindications to etanercept.

Acute viral bronchiolitis in infants: A narrative literature review

Severe acute bronchiolitis is mostly caused by the respiratory syncytial virus (RSV) and is the main cause of hospitalization in children under one year old. Although it has a low mortality rate, it has a high morbidity rate, requiring early diagnosis through a detailed clinical history and physical examination. A narrative review of fourteen articles found in the PubMED/MEDLINE, SciELO and BVS electronic databases was therefore carried out, with the aim of reviewing the most up-to-date literature on the subject. Currently, the monoclonal antibody Palivizumab is the main agent used to prevent bronchiolitis and is available for patients at high risk of developing the serious disease. In addition, the Abryso vaccine was recently approved by the National Health Surveillance Agency (Anvisa) and will be administered to pregnant women in the last trimester of pregnancy, with the aim of preventing the disease in newborns. Finally, it was found that the appropriate management of acute viral bronchiolitis consists of supportive measures such as hydration, nutritional support and oxygenation when necessary, while the use of corticosteroids and bronchodilators has not been shown to reduce the length of hospital stay or the natural course of the disease.

Transfusion reaction - Signs and symptoms and hemovigilance interventions

The aim of this study was to review the literature on transfusion reactions - signs and symptoms and hemovigilance interventions. This is a bibliographical review of the literature. Scientific materials were used from the databases - Latin American and Caribbean Literature in Health Sciences - Lilacs, and Scientific Electronic Library Online - Scielo, and articles related to "Blood component transfusion" were selected. Despite the regulations and the efforts of the National Health Surveillance Agency (ANVISA), together with the sentinel networks, there is still under-reporting of transfusion reactions in Brazil. This makes it more difficult to control and recognize occurrences. Transfusion reactions cause varying degrees of damage to the patient and can be immediate: when signs and symptoms appear during the blood transfusion or up to 24 hours after the start of infusion therapy. As an integral part of the health system, all health professionals must achieve an optimum standard of patient care, prioritizing quality care and good practices in the management of patients who need to be transfused.

Pragmatic Carbohydrate Quality Metrics in Relation to Glycemic Index, Glycemic Load, and Front-of-Pack Warning Labels in Grain Foods.

The challenges in the characterization of the nutritional quality of grain foods comprise obstacles to public health actions toward promotion of healthier grain-based foods. The present study investigated how carbohydrate metrics related to glycemic index (GI), glycemic load (GL), and warning labels of grain foods consumed by individuals living in São Paulo, Brazil. Information on intake of grain foods at individual level was obtained using 24 h recalls within a cross-sectional population-based survey conducted in 2015. There were 244 unique grain products reported by individuals in the survey, assessed through four metrics of carbohydrate quality, considering contents per 10 g of total carbohydrate: (1) ≥1 g fiber, (2) ≥1 g fiber and <1 g free sugars, (3) ≥1 g fiber and <2 g free sugars, and (4) ≥1 g fiber, and <2 g free sugars per 1 g of fiber. Outcomes included GI, GL, and inclusion of warning labels proposed by the Brazilian National Health Surveillance Agency (ANVISA), the Chilean Ministry of Health (1st and 3rd stages), and the Pan American Health Organization (PAHO). Metrics identified products with lower mean GI (-12.8 to -9.0 [p-values < 0.001]), and GL (-12.5 to -10.3 [p-values < 0.001]). Warning systems showed a certain degree of discrimination between products according to the metrics (p-value < 0.01 each); however, >50% of products with good nutritional quality according to the carbohydrate metrics still would receive warnings. Findings suggest that carbohydrate metrics identified products with lower GI and GL, and current warning labels may not adequately capture overall nutritional quality of grain foods.

Harm caused by the use of lisdexamfetamine to increase the academic performance of medical students: integrative review

Lisdexamfetamine (LIS) is a central nervous system stimulant used to treat Attention-deficit/hyperactivity disorder (ADHD), improving attention, concentration and reducing hyperactivity. However, it is important to highlight that the National Health Surveillance Agency (ANVISA), the regulatory body for medicines in Brazil, does not recognize the efficacy and safety of LIS outside of its indications contained in the medicine leaflet and, in addition, the inappropriate use of this substance becomes a risk factor for the occurrence of anxiety, cardiac arrhythmias and glaucoma. This is an integrative literature review carried out in PubMed, LILACS and SciELO databases searching the descriptors “Lisdexamfetamine”, “ADHD”, and “Students”. Around 23.3% of medical students use these substances to overcome fatigue and improve performance, with Ritalin and Venvanse being the most common. However, 57.1% use these medications without a prescription or diagnosis of ADHD, obtaining them illegally. In general, all medications should only be used after medical evaluation and verification of real need, however, in the case of psychostimulants, caution must be even greater. Therefore, it is crucial to raise awareness among patients who are not diagnosed with ADHD about the long and short-term implications of self-medication with LIS, seeking to combat this public health problem.

The role of health surveillance in the face of self-medication in the context of Covid-19: A literature reviewha

The politicization of the disease led to misinformation and the use of unproven treatments, such as the “COVID Kit”. The National Health Surveillance Agency (ANVISA) took important measures, including management and planning, health risk control, regulation, monitoring of suspected and confirmed cases, as well as information, communication and health education. Therefore, the general objective of this research is to demonstrate how the National Health Surveillance Agency (ANVISA) acted in the face of self-medication in the context of COVID-19. To this end, a literature review was carried out over the last five years on self-medication, pandemics, health surveillance, using databases such as PubMed, Google Scholar, Scientific Electronic Library Online (SciELO), Manuals from the Ministry of Health and the World Health Organization Inclusion criteria were adopted, such as articles published in Portuguese or English, primary studies and literature reviews, while studies that did not meet the general objective of the work and publications prior to 2019 were excluded. Regarding the results, ANVISA played an important role in the control and regulation of medicines during the pandemic, classifying chloroquine as a special control medicine and carrying out more than 30 thousand inspections to ensure compliance with clinical protocols to combat the disease. Finally, the pandemic brought challenges for health surveillance professionals, in order to contain the spread of the coronavirus, especially regarding the inappropriate use of medicines and other products subject to health assessment.

Challenges and opportunities for access to Advanced Therapy Medicinal Products in Brazil

Background aimsThe marketing authorization of Advanced Therapy Medicinal Products (ATMPs) in Brazil is recent. The features of these therapies impose specialized regulatory action and are consequently challenging for developers. The goal of this study was to identify the industry's experience in clinical development, marketing authorization and access to ATMPs through the Unified Health System (SUS, acronym in Portuguese), from a regulatory perspective. MethodsA survey containing structured questions was conducted among research participants who work at companies that commercialize ATMPs. A descriptive analysis was performed. ResultsWe invited 15 foreign pharmaceutical companies, of which 10 agreed to participate. Overall, participants assessed that Brazil has a well-established regulatory system, especially the sanitary registration by the National Health Surveillance Agency (Anvisa), which ensures the quality, safety, and efficacy of the products. The Agency's good interaction with the regulated sector, the harmonization of sanitary and ethical assessment systems with other countries, and the analysis time in the biosafety assessment of Genetically Modified Organisms (GMOs) stand out as positive in industry's evaluation. On the other hand, it is important to advance the pricing regulation for these products since Brazilian regulations do not establish specific criteria for ATMP. One of the biggest challenges is the difficulty for the SUS in reimbursing these very high-cost therapies, especially using current Health Technology Assessment (HTA) methods. ConclusionsConsidering the increasing number of approvals of cell and gene therapies in Brazil in the coming years, a close dialogue between the industry and the public sector is recommended to advance regulatory improvements (pricing and HTA). Additionally, the construction of policies to promote the national Health Economic-Industrial Complex, based on a mission-oriented vision that encourages innovative models of financing, especially those that consider risk-sharing and co-financing technologies, will help provide the population with universal, equitable and sustainable access to ATMP in the SUS.

Evaluation of Brazilian pesticide residue reported by monitoring programs considering foods offered to childrens

The consumption of fruits and vegetables, which are the basis of infant nutrition, carries a high risk of pesticide residue contamination. With higher food intake and lower body weight, infants can be considered more sensitive to contamination than adults, which justifies the growing concern about the diet of this population in recent decades. In 2006 in the European Union (EU), processed baby foods were regulated and should not contain individual pesticide residues at levels higher than 0.01 mg/kg, to protect children from ingesting harmful substances. Considering the reference pesticide residues for infant food in the EU and the pesticide residue monitoring programs in Brazil (from the National Health Surveillance Agency and the Ministry of Agriculture, Livestock and Supply), this study compared the results of pesticide residues in some vegetables and fruits with the maximum residue level (MRL) for infant foods established by the EU. 10,174 vegetable samples were analyzed by the monitoring programs, and 80.3% were in accordance with their respective MRLs. Some foods, such as rice, potatoes, and chayote, have average pesticide residue levels equal to or lower than the EU-baby-MRL. However, only 44.0% of the analyzed foods presented residues with results lower than 0.01 mg/kg of food. It can be concluded that most fruits and vegetables contain pesticide residues above the EU recommendations for infant food.

Physico-chemical, microbiological, nutritional composition and sensory analysis of products enriched with mechanically separated meat of marine fish

Fish processing technologies are in full development with new techniques and product formulations. The objective of this work is the development and analyze the physical-chemical, microbiological, nutritional and sensory composition of three formulations of products included based on mechanically separated meat -MSM of marine fish: (1) anchovy meatball, (2) sardine kibbeh and (3) chocolate cake. Sensory analyzes were performed with an untrained public. Each taster received three samples, one of each product and a questionnaire based on the 7-point Hedonic Scale. For the chemical characterization, the analysis protocols of fish products processed according to the legislation were used. The microbiological analyses were carried out in accordance with the recommendations of the National Health Surveillance Agency (ANVISA) for fish-based foods. The nutritional analysis was performed by calculations based on the chemical composition of the developed products. The results of the analyses were favorable for the development of new food products based on mechanically separated marine fish meat for a wide variety of markets.

The pharmaceutical patent process: National Health Surveillance Agency and National Institute of Industrial Property act differently in the process

The National Institute of Industrial Property (INPI) is the government body responsible for granting patents in the national territory; in the case of medicines, they need to be registered with the National Health Surveillance Agency (ANVISA) in order to be marketed. There was a divergence in legal interpretation (of Art. 229-C of the IPL) which caused damage to entrepreneurs, laboratories and the community in general, as there was no express provision as to whether ANVISA's opinion would be binding on the INPI's decision on patent issues. The aim of this research was to analyze this problem, raising its main points and demonstrating how dangerous and damaging bureaucracy and inefficient and obscure normative acts that give rise to dubious interpretation can be, based on the application of hermeneutic and dialectical methods. In 2021, the Superior Court of Justice (STJ), in Special Appeal n. 1543826, held that ANVISA's opinion would be a valid prerequisite for granting patents for pharmaceutical products or processes. It was found that the STJ decision increased ANVISA's "powers", but with the repeal of Art. 229-C of the IPL, the dilemma was extinguished and the competencies of each body re-established. It is therefore of the utmost importance to fill legal gaps and issue clear and specific laws so as not to leave room for harmful interpretations, guaranteeing original competences and legal certainty.

Biological parameters for quality evaluation of allografts from the Brazilian National Institute of Traumatology and Orthopedics tissue bank.

Bone allografts are clinically used in a variety of surgical procedures, and tissue banks are responsible for harvesting, processing, quality testing, storing, and delivering these materials for transplantation. In tissue banks, the bone is processed for the removal of all organic content, remaining only the tissue structure (scaffold). However, several studies have shown that even after using different processing methods, viable cells, functional proteins, and DNA may still persist in the tissue, which constitute the main causes of graft rejection. Therefore, the objective of this study was to establish techniques and biological parameters for quality validation of allografts. To this end, we propose the use of 3 combined methods such as microscopy, histology, and molecular biology techniques to evaluate the quality of allografts harvested and processed by the Brazilian National Institute of Traumatology and Orthopedics (INTO) tissue bank according to the donation criteria of the Brazilian National Health Surveillance Agency and the Brazilian National Transplant System. Bone fragments from different processing stages showed no viable cells on histology, an intact extracellular matrix on scanning electron microscopy, and gradual reduction in DNA amount. Different techniques were used to demonstrate the quality of allografts produced by the INTO tissue bank and to establish biological parameters for ensuring the safety and quality of these products. Future studies need to be undertaken to assess and validate the efficacy of the decellularization process in larger bone grafts with diverse architectural configurations.