On July 15, the National Administration of Medicines, Food and Medical Technology (ANMAT, for its acronym in Spanish) established, via Regulation 4827/2020, that the Advisory Commission on Bioequivalence-Bioavailability had to issue an opinion on medicines containing new active pharmaceutical ingredients for the domestic market when including these on the Registry of Medicinal Specialties. This standard is already in effect.

The ANMAT may issue special considerations and advise on updating the standards applicable to bioequivalence, bioavailability, in-vitro equivalency and bio-exemption studies, for medicines containing new active pharmaceutical ingredients for the national market.

Due to the COVID-19 health emergency, the requirement to implement Bioequivalence Studies for antineoplastic drugs according to Regulation No. 8398/18 is to be suspended, at the suggestion of the Evaluation and Drug Registry Department (DERM, for its acronym in Spanish).