ANMAT regulatory update–Bioequivalence/Bioavailability

On 01/20/2026, ANMAT Salud published Disposition 47/2026 in the Official Gazette, updating the list of Active Pharmaceutical Ingredients (APIs) that must undergo bioequivalence / bioavailability studies.

The update adds oral hypoglycemic agents – categories II and IV, creating for many laboratories an immediate need to plan new studies and adjust timelines.

At FP Clinical Pharma, with 25 years of experience and more than 300 successful projects for the pharmaceutical industry, we are prepared to support you through this new regulatory scenario, with a technical, agile and strategic approach.