EMA adopts ICH guideline E17

ICH guideline E17 on general principles for planning and design of multi-regional clinical trials coming into effect in June 2018

With the increasing globalization 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 program 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.

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