If Brazil today is among the countries active in the global scenario of clinical research, much is due to the National Health Surveillance Agency (ANVISA). Its performance has been and has been increasingly important and fundamental, since it has gone from passive to active agent in the processes of release of studies and products.
The beginning and the main milestone
Although the beginning of clinical research in Brazil has faced, among other issues, this position as a spectator of Anvisa, the picture has changed gradually. The agency became more involved in evolving and making the clinical research sector evolve as well.
According to Leandro Lozano, consultant on regulatory affairs for Abracro, in 2014 there was a large water splitter for the sector. This year, the current legislation in force was created, which was thought together with organs and even with important contributions from Abracro.
This legislation concerns not only the study and the product, but includes the development plan for the drug. "Anvisa wanted to better understand and deepen knowledge about what was going on, becoming a more decisive actor in the development of medications," Lozano says.
Essential contribution to clinical research
From the moment Brazil began to have more solid legislation in clinical research, it gained greater projection at global level. "The more we are within the world trends, the more we become a more attractive country for the sector," Leandro says.
As soon as Anvisa was involved and sought that the sector be within the required levels, Brazil won, becoming more competitive. "With this, we began to worry about the studies being aligned with the global quality standard. This raises a lot of the level of studies, "Lozano says.
Quality of Anvisa
With every increase in demand made and thought by Anvisa, the sector consequently evolves. "This helps us show the world that we can do better," Lozano says. Thanks to the open and frank dialogue established between Anvisa and Abracro, the clinical research in Brazil gains more strength. A necessary and very welcome force, assures Lozano.