1. Executive Summary

This workbook provides an overview of the current regulatory landscape in the Philippines in relation to decentralized Clinical Trials (“DCT”). The Philippines abide by the regulations set forth by the Department of Health (DOH) and the Food and Drug Administration (FDA). The regulations in the Philippines are largely based on those of the USA. 

Fully decentralized trials have not been conducted in the Philippines; however, elements of decentralization have been incorporated into local studies recently. There are no regulations outlawing the use of these decentralized elements of clinical trials.