1. Executive Summary

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Indonesia in relation to Decentralized Clinical Trials (“DCT”). Clinical Trials are governed in Indonesia by the Drug and Food Supervisory Board (Badan Pengawas Obat dan Makanan or BPOM) with additional oversight provided at an institutional level by local ethics committees.

The conduct of clinical trials in Indonesia is generally quite limited and focused on locally developed products. Healthcare infrastructure is generally modest in even the larger cities and the adoption of technology has been slow. As a consequence, no DCTs have been conducted in Indonesia to date. The use of electronic systems is very limited but pilot trials are now being conducted with a view to future expansion. This is likely to increase the potential for decentralized or hybrid trials in the future.