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 some strategic programme issues as well as those issues that are specific to the planning and design of confirmatory MRCTs and should be used together with other ICH guidelines, including E2, E3, E4, E5, E6, E8, E9, E10 and E18.

 

Posted on the FDA website on 8 September 2016