1. Executive Summary

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Mexico in relation to Decentralized Clinical Trials (“DCTs”). Clinical trials in Mexico are regulated by the Federal Commission for the Protection Against Sanitary Risks (Comision Federal para la Protecciõn contra Riesgos Sanitarios (COFEPRIS).

Full DCTs have not yet been conducted in Mexico. Mexico has been slow to adopt technology to support clinical trials and still relies heavily on hard-copy documentation.