Regulations in Brazil are Changing

API regulation affairs in Brazil

On April 1st, 2020, Brazil’s ANVISA published new landmark regulations referring to active pharmaceutical ingredients (APIs). This new set of rules consists of three separate guidelines for local pharmaceutical segment stakeholders, known as “RDCs”. These are RDC 359/2020, RDC 361/2020 and RDC 362/2020, and they represent a complete overhaul of the API regulatory landscape in