1. Executive Summary

This workbook provides an overview of the current and proposed regulatory landscape applicable in Malaysia in relation to Decentralized Clinical Trials (“DCT”). Malaysia abides by the regulations set forth by the National Pharmaceutical Regulatory Agency (NPRA), an agency under the Malaysian Ministry of Health (MOH).

Fully DCTs have not yet been conducted in Malaysia. However, hybrid studies have been conducted with an increasing acceptance of decentralized aspects of study design following the COVID-19 pandemic.