Argentina
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)
Argentina is regulated by the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), a deconcentrated body of the Ministerio de Salud created by Decree 1490/1992 under Law 16.463 (Ley de Medicamentos). ANMAT regulates medicines, biologics, biosimilars, medical devices, IVDs, vaccines, blood products, food and cosmetics. The core medicines framework is set by Decree 150/1992 (modified by Decree 177/1993) plus ANMAT Disposición 5904/1996 (labelling/leaflets), 7075/2011 (registration requirements), 6677/2010 (GCP / clinical pharmacology), 5358/2012 (Good Pharmacovigilance Practices), and 1741/2025 (biosimilars). Argentina operates a tiered reliance framework based on country-of-origin: Annex I countries ("high-vigilance" — US, EU Member States, UK, Switzerland, Canada, Japan, Australia, Israel, Sweden, Denmark, etc.) qualify for an abbreviated route under Decree 150/92; products approved by these reference authorities can be registered through a shortened review (~120 days). ANMAT is a PIC/S full member (since 2008), an ICH Regulatory Member (admitted June 2024), a PANDRH founding member, and chairs the MERCOSUR pharmaceutical harmonisation working group. Argentina is the third-largest pharmaceutical market in Latin America (after Brazil and Mexico). The market combines a strong domestic generics industry, a public sector (provincial and national hospitals plus PAMI for retirees), social-security plans (Obras Sociales) and prepaid medicine (medicina prepaga). Pricing is monitored but not directly controlled; reference pricing applies to PAMI and Obras Sociales coverage. CONETEC (Comisión Nacional de Evaluación de Tecnologías Sanitarias y Excelencia Clínica) provides national HTA recommendations.
About the authority
ANMAT is structured around three institutes: INAME (Instituto Nacional de Medicamentos — drug registration, GMP inspections, vigilance), INAL (food) and the Dirección de Productos Médicos (medical devices). Drug registration sits with INAME's Dirección de Evaluación y Registro de Medicamentos (DERM); clinical trial authorisation with the Dirección de Evaluación de Medicamentos – Departamento de Ensayos Clínicos. Submissions are filed through the Trámites a Distancia (TAD) electronic portal of the national government.
International affiliations
Reliance & recognition
Argentina's Annex I framework under Decree 150/92 designates "high-vigilance" countries whose marketing approvals trigger a shortened registration route at ANMAT. Reliance is limited to country-of-origin (the product must be approved AND marketed in an Annex I country) — ANMAT does not yet operate a broader work-sharing scheme. ICH Regulatory Membership (June 2024) and PIC/S full membership underpin further convergence.
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