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

May 29, 2017
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) is April 1, 2018.

Stakeholders will be consulted during the implementation process regarding the development of a guidance document based on ICH E6(R2) and Part C Division 5 of the Food and Drug Regulations. This guidance document will address implementation of ICH E6(R2) in the Canadian context, address frequently asked questions on Health Canada's expectations under Part C Division 5 of the Food and Drug Regulations, and provide guidance in areas where deficiencies are commonly found during inspection. In addition, Health Canada plans to develop training programs for stakeholders and internal staff prior to implementation of ICH E6(R2).

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:

Pharmaceutical Drug Products
Office of Clinical Trial
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
5th Floor, Holland Cross, Tower B
1600 Scott St.
Address Locator: 3105A
Tunney's Pasture
Ottawa, ON K1A 0K9
Telephone: 613-954-6494

Inspection/Compliance & Enforcement
Clinical Trial Compliance Program
Medical Devices and Clinical Compliance Directorate
Regulatory Operations and Regions Branch
Health Canada
Building #19, 200 Eglantine Driveway
Address Locator: 1914C
Tunney's Pasture
Ottawa, ON K1A 0K9

Please include "Implementation of ICH E6(R2)" in the subject line.

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