On September 5, 2025, the National Administration of Medicines, Food, and Medical Technology (ANMAT) issued Provision No. 6559/2025, expanding the requirement of bioequivalence and/or bioavailability studies to oral pharmaceutical forms of hypoglycemic drugs.
This measure applies to medicinal products whose active pharmaceutical ingredients (APIs) are listed in Annex I of the Provision. The APIs covered include, among others: Canagliflozin, Glibenclamide, Gliclazide, Glimepiride, Glipizide, Metformin (extended-release), Repaglinide, Pioglitazone, and various fixed-dose combinations.
Most of these APIs fall under Biopharmaceutical Classification System (BCS) classes II and IV, which represent low solubility and varying levels of permeability. Annex II specifies the reference pharmaceutical products that must be used for the bioequivalence trials.
Compliance requirements:
- Results of bioequivalence studies must be submitted within 180 calendar days from publication in the Official Gazette (September 8, 2025).
- Non-compliance or negative results will lead to suspension of marketing authorization for the products involved, unless public health reasons justify exceptions.
- Companies with formulations proportionally similar to a multi-source product already proven bioequivalent may demonstrate equivalence through in vitro studies.
This regulatory development strengthens Argentina’s commitment to ensuring quality, safety, and efficacy of hypoglycemic medicines in line with global standards.