Will Brazil have any new genetic or cellular therapy products registered at ANVISA by the end of 2021?
Market Rules
On February 18th, 2020, the Brazilian Health Agency, ANVISA, approved the rules for the registration of new advanced therapy products. Such definition includes products related to therapies that modify the patient's DNA and the use of modified cells to fight cancer, for example.
Before the approval of these rules, only clinical trials were possible in the country - by February 2020 eight such clinical trials were being monitored, and three more were under analysis. With the approval, however, Brazil now has the necessary regulatory bases to develop and register high-tech products based on human cells and genes, becoming a reference in Latin America.
If by December 31st, 2021, any new advanced therapy product - be it based on genetic or cellular therapy - is registered at ANVISA, this question will be resolved as "Yes"