Canada: Health Canada implements ICH Guideline on multi-regional clinical trials

16-04-2019

Canada: Health Canada implements ICH Guideline on multi-regional clinical trials

(Source: RAPS 2019-04-17)

Health Canada last Friday said it has implemented International Council for Harmonisation’s (ICH) E17 guideline from November 2017 on multi-regional clinical trials (MCRTs).

Health Canada’s adoption of E17 follows the European Medicines Agency’s implementation in June 2018, Japan’s MHLW/PMDA implementation also in June 2018 and the US Food and Drug Administration’s implementation in July 2018.

As drug development becomes increasingly global, ICH said the guideline was necessary because regulators face challenges in evaluating data from MRCTs for drug approvals. The guideline focuses on scientific issues in planning/designing MRCTs and is meant to complement ICH’s E5(R1) guideline on ethnic factors in the acceptability of foreign clinical data.

“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,” the guideline notes.

How treatment effects vary across regions and populations under a single study protocol, and how these variations may be explained by intrinsic and extrinsic factors, are also part of the guideline’s goals.

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