ICH E17 Guideline 1. INTRODUCTION 1.1. 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 ap- proval 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 accepta- bility of MRCTs in global regulatory submissions.
The guideline addresses strategic pro- gramme issues as well as issues that are specific to the planning and design of confirma- tory MRCTs, and it should be used together with other ICH guidelines, including E5, E6, E8, E9, E10, and E18. 1.2. Background In the era of globalisation of drug development, it may be challenging to conduct a drug development programme globally, in part due to distinct and sometimes conflicting re- quirements from regulatory authorities. At the same time, regulatory authorities face in- creasing challenges in evaluating data from MRCTs for drug approval.
Data from MRCTs are often submitted to multiple regulatory authorities without a previously har- monised regulatory view on the development programme. There are currently no ICH guidelines that deal specifically with the planning and design of MRCTs, although the ICH E5 guideline covers issues relating to the bridging of results from one region to an- other. MRCTs conducted according to the present guideline will allow investigation of treat- ment effects including safety evaluations in the overall population as well as investiga- tions of the potential impact of intrinsic and extrinsic factors (described as ethnic factors in the ICH E5 guideline) on the treatment effect.
MRCTs, which are properly designed and executed according to this guideline, may facilitate more efficient drug development and increase the possibility of submitting marketing authorisation applications to multiple regulatory authorities in different regions simultaneously, thus providing earlier access to new drugs worldwide. In addition, MRCTs conducted according to the present guideline 1