From pharmacokinetic studies to Phase I: regulatory news and updates from the pharmaceutical industry.
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.
Read moreDr. Ethel Feleder, our Director, was selected by ANMAT to join the Network of Experts in Pharmacological Clinical Research, becoming a member of the Advisory Committee.
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Bioequivalence affects not only treatment quality, but also everyday clinical decisions. With the help of an expert, we explore the scope of the terms and regulations involved.
Read moreThis National Administration has decided to conduct a full evaluation of the results submitted under the terms of Disposition 2434/13, in conjunction with Disposition 5640/22, in certain cases.
Read moreUnder ANMAT Disposition DI-2023-5343-APN-ANMAT#MS, the results of the Bioequivalence Study designed, conducted and analyzed by FP Clinical Pharma for Laboratorio BETA were accepted.
Read moreUnder Disposition DI-2023-6029-APN-ANMAT#MS dated August 7, 2023, ANMAT renewed FP Clinical Pharma S.R.L.'s authorization to conduct Phase IV Clinical Pharmacology Bioequivalence Studies in the adult population.
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