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- Good Regulatory Practices: ANVISA’s Regulatory Model for Brazil
ANVISA’s role is to promote the protection of the population’s health by controlling the production, marketing, and use of products and services subject to health regulation ANVISA’s current regulatory model has been in force since April 2019 as a means to improve Brazil’s health standards
- Cómo está preparando ANVISA su camino para convertirse en una agencia . . .
ANVISA reconoce que los retos en el camino para convertirse en una WLA han sido muchos, pero también han permitido el crecimiento hacia una organización más madura: se estableció un sistema común de gestión de la calidad para toda la agencia y se revisaron y adoptaron procedimientos operativos estándar (POEs) para numerosas actividades
- How Brazilian Regulator ANVISA is Paving Its Way to Become a Global . . .
ANVISA acknowledges that the challenges in the path to become a WLA have been many, but they have also allowed for the growth of a more mature organization: a common quality management system for the entire agency was established and standard operating procedures (SOPs) for numerous routine activities, including international cooperation
- ANVISA-COFEPRIS Strategy and Vision
ANVISA and COFEPRIS regulate the largest Latin American markets for products subject to health product surveillance, with complex industrial parks, numerous populations, and government participation in the provision of health products and services
- Estratégia e Visão ANVISA-COFEPRIS
ANVISA e COFEPRIS regulam os maiores mercados latinoamericanos de produtos sujeitos à vigilância sanitária, com parques industriais complexos, numerosa população, e participação do Governo na prestação de produtos e serviços à saúde
- Regulatory Systems, Trends, and Innovations in Latin America and the . . .
For example, ANVISA in Brazil utilizes systems such as Notivisa and e-Notivisa for adverse event reporting for medical devices and VigiMed for engaging healthcare professionals, the public, drug registration holders, and study sponsors on suspected adverse events related to drugs and vaccines
- RWD and RWE in Brazil: Perspective of the Brazilian Health Regulatory . . .
Anvisa’s Regulatory Initiatives on the Use of RWE Generated by RWD In order to reduce those uncertainties and to increase confidence in RWE in regulatory decision-making, Anvisa has been seeking to increase its knowledge of these topics
- Expedited Regulatory Pathways in Established and Emerging Markets
The panel provided a variety of perspectives ranging from the US FDA, EMA, and Japan PMDA as agencies with well-established expedited registration pathways, to agencies like China CDA, Korea MFDS, ANVISA, and others that have established or updated such pathways in the past year
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