Results 1 to 10 of about 54,042 (241)

ANVISA APPROVES THE FIRST BIOSIMILAR MONOCLONAL ANTIBODY BASED ON COMPARABILITY IN BRAZIL [PDF]

Arquivos de Gastroenterologia, 2016
. This measure by ANVISA is primarily aimed at cost reduction, because most of the individuals currently using IFX can only do it due to reimbursement by the Brazilian public health system. The achieve-ment is commendable and approved by all medical societies involved, in the specialties of rheumatol-ogy, gastroenterology and dermatology.
Fábio Vieira Teixeira, Paulo Gustavo Kotze, Adérson Omar Mourão Cintra Damião   +2 more
semanticscholar   +6 more sources

A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013–2016 [PDF]

Therapeutic Innovation & Regulatory Science, 2020
Abstract Background The Brazilian health regulatory agency (Agência Nacional de Vigilância Sanitária, ANVISA) has embarked on transformational initiatives to fulfill its mandate to provide timely access to safe, effective, and quality therapeutics. A new Brazilian law was enacted to provide the agency with greater flexibility.
Prisha Patel, Daniela Marreco Cerqueira, Gustavo Mendes Lima Santos, Renata de Lima Soares, Varley Dias Sousa, Lawrence Liberti, Neil McAuslane   +6 more
semanticscholar   +5 more sources

Medicamentos sem registros na ANVISA : uma abordagem institucional [PDF]

Revista Brasileira de Políticas Públicas, 2018
Este artigo possui por objeto, a partir da abordagem institucionalista, a investigação dos níveis de deferência dos Poderes Legislativo e Judiciário à Agência Nacional de Vigilância Sanitária (ANVISA). Metodologicamente, serão analisadas decisões judiciais e legislativas que preterem as prerrogativas da ANVISA no que se refere à permissão de acesso a ...
Igor De Lazari, Carlos Bolonha, Sérgio Bocayuva Tavares de Oliveira Dias   +2 more
semanticscholar   +4 more sources

A pré-qualificação de medicamentos: análise comparativa entre OMS e Anvisa [PDF]

Vigilância Sanitária em Debate, 2017
A produção de medicamentos com qualidade, segurança e eficácia é fundamental para atender às demandas nacionais e internacionais, com o fito de subsidiar a assistência farmacêutica no âmbito da saúde pública. Diante do papel estratégico em que o complexo fabril público de saúde está inserido, o cumprimento das Boas Práticas de Fabricação (BPF) da ...
Marcus Vinícius Lima do Couto, Fernando Medina, Hudson Eduardo Souza da Costa, Silvania Iacovino Dantas, Jorge Antônio Zepeda Bermudez, Norberto Rech, Jorge Carlos Santos da Costa   +6 more
semanticscholar   +9 more sources

The Police Power of the National Health Surveillance Agency – ANVISA

Archives of Cancer Science and Therapy
The National Health Surveillance Agency (ANVISA) is a public institution created by Law 9782/1999, which integrates the field of Collective Health and acts in the prevention, control, and inspection of sanitary conditions in various sectors, such as food, health, pharmacies, hospitals, and commercial establishments.
da Silva Dimas Augusto, da Silva Rafaela Marinho   +1 more
semanticscholar   +3 more sources

Recentes resoluções da Anvisa Latest resolutions by Anvisa [PDF]

Revista de Saúde Pública, 2004
doaj   +7 more sources

Analysis of Brazilian Manufacters in the COVID-19 Diagnostic Products by ANVISA

JOURNAL OF BIOENGINEERING AND TECHNOLOGY APPLIED TO HEALTH, 2020
In March 2020, the World Health Organization (WHO) declared COVID-19 as a pandemic. Diagnostic and screening tests have been important tools for the clinical characterization of diseases such as COVID-19. This study aimed to analyze the presence of Brazilian manufacturers in the COVID-19 products approved by the Brazilian Health Regulatory Agency ...
Valdir Gomes Barbosa Júnior, Roberto Badaró, Bruna Aparecida Souza Machado   +2 more
openalex   +3 more sources

ANVISA: an introduction to a new regulatory agency with many challenges [PDF]

AAPS Open, 2018
Abstract Brazil, the largest country in South America, has become the second largest pharmaceutical market in the emerging world. The Brazillian Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria - ANVISA) was created in 1999 with the primary goal to protect and promote public health surveillance over products and services in Brazil ...
Alexandra Beumer Sassi, Kim Huynh-Ba
openaire   +4 more sources

Medical devices registration by ANVISA (Agência Nacional de Vigilância Sanitária) [PDF]

Clinics, 2011
Dear Editor, The term “medical devices” covers a wide range of health or medical instruments used directly or indirectly in medicine, dentistry, physical therapy, and laboratory practice for the diagnosis, rehabilitation, therapy, and monitoring of human beings, as well as for aesthetic purposes.
Aline Fernanda Perez Machado, Bernardo Hochman, Pascale Mutti Tacani, Richard Eloin Liebano, Lydia Masako Ferreira   +4 more
openalex   +7 more sources

Compilation About Adverse Events Recorded in FDA/ USA and ANVISA/Brazil Databases Through Models Available in the Literature Concerning Analysis and Prioritization of Actions for Medical Devices

, 2021
The use of medical technologies has grown steadily in all health fields, offering numerous benefits to patients. However, related adverse events, which may cause severe consequences for patients, also have increased.
Josiany Carlos de Souza, Sheida Mehrpour, Matheus Modolo Ferreira, Yves Coelho, Gustavo De Castro Vivas, Denis Delisle-Rodríguez, Francisco de Assis Viana dos Santos, Teodiano Bastos-Filho   +7 more
openalex   +3 more sources