Argentina's ANMAT simplifies approval process for vaccines and biologics

The National Administration of Drugs, Food and Medical Technology (ANMAT) in Argentina issued Disposition No. 4351/2026, creating a new regulatory framework for the presentation, evaluation and authorization of modifications to already‑registered biological medicines such as vaccines and blood products. The measure aims to simplify procedures, introduce risk‑based review categories, set maximum resolution times and incorporate a reliance mechanism that allows ANMAT to consider prior assessments by international reference authorities like the U.S. FDA or the European Medicines Agency, provided they suit the national context.

Science researcher Sandra Pitta welcomed the change, noting it could speed the availability of treatments and potentially lower prices by reducing bureaucratic steps. She cautioned, however, that Argentina’s broader challenge lies in the quality of generic drugs, many of which lack bioequivalence studies and are essentially copies rather than true generics. Pitta emphasized that without biodisponibility testing, the therapeutic equivalence of locally produced medicines remains uncertain.