International – Guideline : General Principles for Planning and Design of Multi-Regional Clinical Trials E17

Objectives of the Guideline

With the increasing globalisation of drug development, it has become important that data
from multi-regional 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 guideline 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. The guideline addresses strategic programme issues as well as issues that are specific to the planning and design of confirmatory MRCTs, and it should be used together with other ICH guidelines, including E5, E6,
E8, E9, E10, and E18…