1. Executive Summary

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Argentina in relation to Decentralized Clinical Trials (“DCTs”).

Argentina abides by the regulations set forth by the National Administration of Drugs, Food and Medical Technology (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica-ANMAT). There is no evidence that a fully decentralized trial has been conducted yet in Argentina. However, elements of trials are being decentralized, particularly since the COVID-19 pandemic.