Issue Date: July 19, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Efficacy
Status: Final
E17 General Principles for Planning and Design of Multi-Regional Clinical Trials
With the increasing globalization of drug development, it has become important that data from multiregional clinical trials (MRCTs) can be accepted by regulatory authorities across regions and countries as the primary source of evidence to support marketing approval of drugs (medicinal products). The purpose of this guidance is to describe general principles for the planning and design of MRCTs with the aim of increasing the acceptability of MRCTs in global regulatory submissions.
Download the Guidance Document
