title: Vaccines in Argentina: a regulatory view.
abstract: In Argentina, vaccines for immuno-preventable diseases are regulated by the national regulatory agency, the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (the National Administration of Drugs, Food and Medical Devices, or ANMAT) created in 1992 to ensure efficacy and safety of drugs, food and medical devices available in the country, according to Law 16,463 and Decree 150/92. ANMAT has licensed 84 out of 157 vaccines registered in Argentina. Since 1994, ANMAT evaluated, approved and inspected 20 clinical trials with vaccines (1.8% of the 1062 trials approved by the agency since that time). The National System of Pharmaco-vigilance has received 318 communications of eventual adverse post-vaccination events (0.3% of the total). In addition, ANMAT provides support to the National Immunisation Programme. The current procedure is to follow international guidelines in the field, to be prepared for new, rapidly changing scenarios.
authors.affiliation: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, Av. De Mayo 869, Buenos Aires, Argentina. aperez@anmat.gov.ar
authors.forename: A C
authors.initials: AC
authors.lastname: Pérez
authors.forename: R A
authors.initials: RA
authors.lastname: Diez
mesh_terms: D001118:Argentina; D006077:Government Agencies; D006801:Humans; D014611:Vaccination / Q000331:legislation & jurisprudence*; D014612:Vaccines / Q000592:standards*
chemical_list: D014612:Vaccines