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Anvisa's Prior Consent as a Contribution to Global Health and the One Health System

Advances in Data Mining and Database Management Book Series, 2022
The participation of the National Health Surveillance Agency (ANVISA) in the granting of patents for pharmaceutical products and processes in Brazil took place since 2001, giving this sector of the Ministry of Health unprecedented legal competence, until then exclusive to the entity of the National Institute of Industrial Property (INPI).
Marilena C Villela Corrêa
exaly   +2 more sources

Internal Standards (IS) Monitoring in CROs: Anvisa Perspective

Bioanalysis, 2019
Gustavo Mendes, Lima Santos   +1 more
exaly   +3 more sources

PP30 The Fast Track In Drug Registration By ANVISA – Brazil And Possible Consequences

International Journal of Technology Assessment in Health Care, 2023
IntroductionThe fast track in drug registration by the Brazilian Health Regulatory Agency, ANVISA, began in 2017 and is intended to prioritize analysis related to drugs relevant to public health. This process is appropriate in situations where there are no therapeutic alternative available or for technologies show significant improvement in safety ...
Silvana Kelles   +12 more
openaire   +1 more source

Access, Fairness and Affordability: Procedural Justice in NICE, Anvisa and Conitec

SSRN Electronic Journal, 2014
Everywhere, health care systems are making hard choices about medicines. These choices are sensitive, controversial and often result in litigation. For example, the recent report in the UK about the drug Tamiflu casts doubt on the efficacy of the treatment and its value for money to the public health system.
Ricardo Perlingeiro, Christopher Newdick
openaire   +1 more source

Should ANVISA be permitted to reject pharmaceutical patent applications in Brazil?

Expert Opinion on Therapeutic Patents, 2013
Pharmaceutical manufacturers who seek new markets for expansion are particularly attracted to Brazil given its potential for growth and the expectation that it will be the fifth largest drug market by 2015. Given the significance of Brazil in the marketplace, strong patent protection for pharmaceutical products and processes is critical. In April 2013,
Lisa L, Mueller   +1 more
openaire   +2 more sources

ANVISA atualiza regras de pesquisa clínica

Brazilian Journal of Periodontology
Isso mesmo, no último dia 2 de dezembro foram publicadas no Diário Oficial da União (DOU) a Resolução1 ANVISA (Agência Nacional de Vigilância Sanitária) nº 945 e a Instrução Normativa2 nº 338, ambas de 29 de novembro de 2024. Na área da Saúde, a busca pelas melhores práticas passa pela disponibilidade de estudos clínicos que assegurem eficácia e ...
openaire   +1 more source

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