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Health Canada Implements ICH Guideline on Good Clinical Practice

Posted 03 April 2019 | By Zachary Brennan 

Health Canada Implements ICH Guideline on Good Clinical Practice

Health Canada said Wednesday that it has implemented the International Council for Harmonisation’s (ICH) guideline on good clinical practice, known as E6(R2).

While working to eliminate the differences between its own and ICH guidances, Health Canada said that in cases of such discrepancies, Health Canada-implemented ICH guidances should take precedence.

The decision to implement the guideline in Canada follows the work of its ICH peer regulatory agencies to implement the guideline over the past two years. The US Food and Drug Administration finalized its version of the addendum in February 2018. Previously, the European Medicines Agency finalized its version of the guideline, which came into effect for the EU in June 2017. And Switzerland amended its Clinical Trials Ordinance (ClinO) to refer to E6(R2) as of 1 May 2017.

ICH explains the changes to the guideline, which was amended in 2016 with an addendum “to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results. Standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency have also been updated.”

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has not yet said when it will implement the new guideline.

Health Canada

 

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Tags: clinical, E6, ICH

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