The ANMAT, Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration of Drugs, Food and Medical Technology) is the descentralized organism of the Ministry of Health that deals with pharmaceutical regulation. Link to ANMAT website (Spanish) Apart from drug products, ANMAT is responsible for the regulation of food, medical devices, reactants for diagnose, cosmetics, dietary supplements and cleaning and other household products.
It was created in 1992 and it has jurisdiction over the whole national territory.
In 2011, the Pan American Health Organization awarded ANMAT the status of Regulatory Authority of Regional Reference for a period of three years. The recognition follows an evaluation of the agency’s performance of basic functions, recommended by WHO, for ensuring the quality, safety and efficacy of medicines in the country.
ANMAT contact details:
Address: Avenida de Mayo 869 (C1084AAD) – Ciudad Autónoma de Buenos Aires – Argentina
Telephone: +54 11 4340 0800
Last update: October 2013
What are the requirements for filing a Drug master file
I would like to know about validation and preference in comparison with FDA and EMA