Overview
- Decree 3/2026, published in the Boletín Oficial, accepted Agustina Bisio’s resignation and appointed surgeon and health executive Luis Eduardo Fontana as ANMAT administrator, effective January 5, 2026.
- The leadership change follows a high‑profile federal case led by Judge Ernesto Kreplak examining contaminated fentanyl and oversight failures at the regulator.
- Investigators have flagged more than 300,000 ampoules produced with deficient practices and commercialized by HLB Pharma and Laboratorios Ramallo under the regulator’s watch.
- Press reports link the case to more than a hundred deaths, with totals varying by outlet, and the judicial and administrative determinations of responsibility remain pending.
- The government highlights Fontana’s private‑sector management background at OSDE and priorities such as traceability, digitalization, and process standardization to strengthen ANMAT’s controls.