Posted 30 May 2017
By Michael Mezher
Health Canada on Tuesday announced that it plans to fully implement an addendum to the International Council for Harmonisation's (ICH) good clinical practice (GCP) guideline in April 2018.
In November 2016, ICH adopted the Integrated Addendum to E6(R1) Good Clinical Practice (E6(R2)), sending the guideline to ICH members for national implementation.
According to ICH, the integrated addendum was developed to address the increased scale and complexity in clinical trials and focuses on improved approaches to clinical trial design, conduct and oversight. Additionally, the addendum updates GCP standards related to electronic records and other documents "intended to increase clinical trial quality and efficacy."
In a presentation in February, ICH said the integrated addendum "provides a unified standard for the European Union, Japan, the United States, Canada and Switzerland to facilitate the mutual acceptance of dat from clinical trials."
Last Thursday, Health Canada's guideline for E6(R2) went into effect, and now the agency says it plans to consult with stakeholders over the next year as it prepares to fully implement the guidelines.
"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," Health Canada writes.
While the European Medicines Agency's (EMA) E6(R2) guideline is set to take effect in June 2017, ICH says it is still awaiting notification from US, Japanese and Swiss regulators on their adoption of the addendum.