Results 1 to 10 of about 49,725 (243)
A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013–2016 [PDF]
Therapeutic Innovation and 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.
Lawrence Liberti, Carol Moreno
exaly +6 more sources
Medicamentos sem registros na ANVISA : uma abordagem institucional [PDF]
Revista Brasileira De Politicas Publicas, 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 ...
Antônio Guimarães Sepulveda +1 more
exaly +5 more sources
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 +2 more
semanticscholar +6 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 +2 more
exaly +4 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 ...
Kaj Blennow
exaly +5 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 +6 more
semanticscholar +9 more sources
Recentes resoluções da Anvisa Latest resolutions by Anvisa [PDF]
Revista de Saúde Pública, 2004 doaj +7 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 +4 more
openalex +7 more sources
Vitamin Dietary Supplement: Changes and Challenges with the New ANVISA Regulations [PDF]
International Journal of Nutrology, 2021 AbstractIn July 2018, the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA, in Portuguese) published new regulations for food supplements, leading to changes both in the sales denomination and labeling statements, and in the composition of these products.
Lucile Tiemi Abe-matsumoto
exaly +3 more sources
Pesquisas agronômicas das plantas medicinais da Mata Atlântica regulamentadas pela ANVISA [PDF]
Revista Brasileira de Plantas Medicinais, 2012 Com a divulgação da lista das espécies medicinais pela Agência Nacional de Vigilância Sanitária (ANVISA), de acordo com a Resolução RDC Nº10, de 09 de março de 2010, o uso dessas plantas passa a ter a chancela oficial do órgão governamental regulamentando seu uso e, em consequência disso, ter sua demanda bastante aumentada.
Lin Chau Ming +2 more
openalex +7 more sources