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Argentina's medicines regulator. It registers medicines, authorises clinical trials of medicines and inspects factories, and a medicine already authorised in one of fifteen named countries can be registered for import through a shorter route.
The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica is a decentralised body within Argentina's Ministry of Health with jurisdiction across the country. Its functions were set by Decree 1490 of 1992: control of the quality and safety of medicines, diagnostics, medical technology, food and cosmetics, and surveillance of adverse effects. Its address is Avenida de Mayo 869, Buenos Aires; the coordinates on this record are approximate.
Medicines are registered under Decree 150 of 1992, in the text ordered by Decrees 1890/92 and 177/93 that ANMAT publishes. Article 3 gives the authority 120 calendar days to decide an application, except for the routes in articles 4 and 5. Article 4 lets a medicine authorised for public use in at least one of the countries in Annex I (the United States, Japan, Sweden, Switzerland, Israel, Canada, Austria, Germany, France, the United Kingdom, the Netherlands, Belgium, Denmark, Spain and Italy) be registered for import automatically, on presentation of the official certificate of that authorisation, labels, leaflets and bioavailability data. Article 5 requires evidence of efficacy and safety for a new medicine not authorised in an Annex I country.
ANMAT states that the Pan American Health Organization re-qualified it in 2017 as a regional reference regulatory authority for medicines and vaccines, that its inspectorate has been a full member of the Pharmaceutical Inspection Co-operation Scheme since 2008, and that it has been a regulatory member of the International Council for Harmonisation since 2024. Its clinical trials area evaluates trials under Disposition 6677/10; an analysis by its own staff of the 327 trials submitted from June 2017 to June 2019 found neoplasms the commonest therapeutic area (79 trials, 24.15%) and a mean evaluation time of 58 working days for the trials it approved (median 52).
Later amendments to Decree 150/92, if any, were not read for this record.
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