Vaccines in Argentina: a regulatory view

Area of Science:

• Vaccinology
• Regulatory Affairs
• Public Health

Background:

• The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) is Argentina's national regulatory agency.
• Established in 1992, ANMAT ensures the safety and efficacy of drugs, food, and medical devices.
• ANMAT regulates vaccines for immuno-preventable diseases in Argentina.

Purpose of the Study:

• To outline the regulatory framework and activities of ANMAT concerning vaccine approval and safety monitoring in Argentina.
• To highlight ANMAT's role in supporting the National Immunisation Programme.

Main Methods:

• Review of ANMAT's licensing data for vaccines.
• Analysis of ANMAT's involvement in clinical trials for vaccines.
• Examination of adverse post-vaccination event reporting to the National System of Pharmaco-vigilance.
• Assessment of adherence to international guidelines for vaccine regulation.

Main Results:

• ANMAT has licensed 84 out of 157 registered vaccines.
• Since 1994, ANMAT evaluated, approved, and inspected 20 vaccine clinical trials (1.8% of total trials).
• 318 adverse post-vaccination events were reported (0.3% of total reports).

Conclusions:

• ANMAT plays a crucial role in vaccine regulation and safety in Argentina.
• The agency actively monitors vaccine safety through clinical trial oversight and pharmacovigilance.
• Argentina's regulatory procedures for vaccines align with international standards to adapt to evolving scenarios.