Notice - Interim Implementation of International Council for Harmonisation (ICH) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)

May 11, 2018
Our file number: 17-105670-233

As a standing regulatory member of the International Council for Harmonisation (ICH), Health Canada is committed to the adoption and implementation of ICH guidance. By way of this Notice, Health Canada is advising of its intent to implement the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). The target date for full implementation of ICH E6(R2) has been extended to April 1, 2019 to allow sufficient time for the training of regulators and stakeholders, which will also include training of ICH E17: Multi Regional Clinical Trials.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected and that clinical trial data are credible.

Description of the Integrated Addendum

The Integrated Addendum ICH E6(R2) provides a unified standard on GCP.

Since the finalisation of the ICH GCP Guideline in 1996, the scale, complexity, and cost of clinical trials have increased. Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities. With this addendum, the guideline has been amended 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.
  • Update standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency.

In this addendum, changes were integrated directly into several sections of the parental guideline.

Contact Information

For any comments or inquiries related to this notice, please contact:

Health Canada – ICH Coordinator
E-mail: HPFB_ICH_DGPSA@hc-sc.gc.ca

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