Argentina
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)
Checked 12 September 2026. No fee amount confirmed.
6 days agoEvery marketing authorisation fee on this profile was checked against the regulator and none could be confirmed from a published schedule. The amounts previously shown here were not traceable to a source and have been removed rather than left in place. Pathways, legal basis, timelines and source links are unchanged. Use the linked authority material for any figure.
Unconfirmed amounts were deliberately removed rather than estimated.
Contributor Wilson Blaney, ACQI, RP (GDP) trained
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 to 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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