1. Executive Summary

This workbook provides an overview of the current and proposed regulatory landscape applicable in China in relation to Decentralized Clinical Trials (“DCT”). China abides by the regulations set forth by the National Medical Products Administration (NMPA). Historically, NMPA has not adopted ICH guidelines but, as of May 2021, NMPA has adopted a number of key ICH guidelines including those relating to the demonstration of efficacy in clinical trials. China still requires clinical data from Chinese patients to support product registration in China.

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