LMR 2026 Update: How Normative Instruction No. 428 Impacts Pharmaceutical Competitiveness

On March, 2026, ANVISA published Normative Instruction (IN) No. 428, bringing crucial updates to the Reference Medicines List (LMR). This movement is vital for companies seeking to register generics and similar drugs, ensuring that bioequivalence and bioavailability studies use the correct comparator.