ICH E17 Multi-Regional Clinical Trails Guidelines


E17 Multi-Regional Clinical Trails

E17 General principles for planning and design of Multi-Regional Clinical Trails

The ICH Harmonised Guideline was finalized under Step 4 in November 2017. This Guideline provides guidance on general principles on planning/designing Multi-Regional Clinical Trial (MRCT). Drug development has been globalised and MRCT for regulatory submission has widely been conducted in ICH regions and beyond. Regulatory agencies are currently facing some challenges in evaluating data from MRCTs for drug approval and it was deemed necessary to developed a Harmonised international Guideline to promote conducting MRCT appropriately, especially focusing on scientific issues in planning/designing MRCTs. This Guideline complements the guidance on MRCTs provided in ICH E5(R1) Guideline and facilitates MRCT data acceptance by multiple regulatory agencies.

An extensive set of training materials including 7 modules has been developed to promote the efficient and consistent implementation of the E17 Guideline in the context of an evolving drug development environment.

Date of Step 4: 16 November 2017

Status: Step 5

Guidelines (Click the links below for complete guidelines)

Endorsed Documents (Click the links below for complete guidelines)

WG Presentations / Trainings (Click the links below for complete guidelines)

*These Guidelines Belongs to ICH website.

ICH E17 Multi-Regional Clinical Trails Guidelines:

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