Through Provision 47/2026 (Official Gazette 01/19/2026), the National Administration of Medicines, Food, and Medical Technology (ANMAT) ordered the incorporation of certain active pharmaceutical ingredients (APIs) into the regime of bioavailability/bioequivalence study requirements and defined the respective applicable reference products. The regulation comes into force on the date of its publication in the Official Gazette.
Access the complete text of the Provision here.
For more information, please contact:
Agustín Siboldi – SiboldiA@eof.com.ar
Jorge Muratorio – MuratorioJ@eof.com.ar