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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
- 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
- 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
- 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
- Collaborative Efforts and Regulatory Harmonization: Progress and . . .
These experiences inspired and supported the development of local regulations of medical products, contributing to regulatory convergence, the progress of innovation, and better health outcomes One illustrative example is the ANVISA-EMA confidentiality arrangement signed in 2021, which is already delivering positive results to both agencies
- ANVISA Explains New Online Optimized Assessment Project
ANVISA Explains New Online Optimized Assessment Project For regulators in Brazil, the pandemic’s aftermath includes a backlog of post-approval changes, delayed by emergency development of COVID-19 vaccines and therapies, related to biologic product quality
- Advancing Global Healthcare Through IDMP Standardsu2028
In September, São Paulo, Brazil, became the focal point of global discussions around healthcare standards through a series of Global IDMP Working Group (GIDWG) meetings, including a public stakeholder meeting co-hosted by the Brazilian Health Regulatory Agency (ANVISA) and the Uppsala Monitoring Centre (UMC)
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