Results 11 to 20 of about 53,339 (246)
A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013–2016 [PDF]
Therapeutic Innovation and Regulatory Science, 2020 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.
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).
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.
Fábio Vieira Teixeira +2 more
semanticscholar +6 more sources
ANVISA: an introduction to a new regulatory agency with many challenges [PDF]
AAPS Open, 2018 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 ...
Kaj Blennow
exaly +5 more sources
A pré-qualificação de medicamentos: análise comparativa entre OMS e Anvisa [PDF]
Vigilância Sanitária em Debate, 2017 The production of medicines with quality, safety and efficacy is essential to meet national and international requirements, aiming at subsidizing pharmaceutical care within the public health. Given the strategic role in which the public health industrial
Marcus Vinícius Lima do Couto +6 more
semanticscholar +9 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
Teoria E Cultura, 2020 O debate sobre a regulamentação do uso medicinal da Cannabis, assim como o cultivo para esse fim e as pesquisas científicas com a planta no Brasil, deu um novo passo com as consultas e audiências públicas 654 e 655 promovidas pela Anvisa ...
Ana Paula Lopes Da Silva Rodrigues
exaly +2 more sources
PLoS ONE, 2018 The circulation of poor quality medicines, especially in the developing countries, is a public health concern. Compliance with good manufacturing practices (GMP) is essential to ensure the quality, efficacy, and safety of medicines.
Andrea Renata Cornelio Geyer +2 more
exaly +2 more sources
Pharmacopeia and ANVISA: A Necessary Symbiosis
Revista Brasileira de Farmácia Hospitalar e Serviços de Saúde, 2017 A basic principle supporting for the use of prescription drugs is the assurance of their quality, safety and efficacy. New drug products require double blind, multicentric randomized controlled clinical trials.
L. M. Lima
semanticscholar +4 more sources
NANOMEDICAMENTOS E OS DESAFIOS DA ANVISA DIANTE DA INEXISTÊNCIA DE UM MARCO REGULATÓRIO NO BRASIL
, 2016 A nanotecnologia, em razao de suas propriedades singulares, pode proporcionar inumeros beneficios em diversas areas estrategicas: saude, eletronica, alimentacao, agricultura, meio ambiente entre outras. Um dos ramos mais promissores e o desenvolvimento e
Liziane Paixão Silva Oliveira +2 more
openalex +2 more sources