Forward Regulatory Plan 2021-2023: Alignment of Clinical Trial Records Retention Timelines
Title of Regulatory Initiative
Alignment of Clinical Trial Records Retention Timelines
Food and Drugs Act
Health Canada proposes to reduce the current records retention requirements in the Food and Drug Regulations and the Natural Health Products Regulations from a minimum of 25 years to a minimum of 15 years, with certain exceptions, for all clinical trials of drugs involving human subjects.
This regulatory initiative was identified in the Fall 2018 Economic Statement and by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap.
This regulatory initiative is associated with Health Canada's stock review plan.
Regulatory cooperation efforts (domestic and international)
This proposal would improve alignment of the records retention requirements for clinical trials in Canada with international standards prescribed by other global health regulators regarding oversight and public access to information on clinical trials.
This proposal would not limit any provincial or territorial law or regulation, including any professional regulations enacted in accordance with a provincial or territorial enabling statute as part of the practice of medicine that may require longer records retention timeframes.
Potential impacts on Canadians, including businesses
The regulatory amendments would reduce the regulatory burden on the industry conducting clinical trials in Canada, encouraging this sector to develop innovative drugs in Canada by providing cost savings as an incentive.
This proposed amendment would reduce regulatory burden to better support the conduct of clinical trials in Canada without compromising the health and safety of Canadians.
The proposal aligns with the Government of Canada’s commitment to modernize federal regulations to support business growth in Canada while continuing to protect the health and safety of Canadians.
As part of a five-month consultation conducted on a guidance in relation to Division 5 of the Food and Drug Regulations, stakeholders raised concerns related to the misalignment of Canada's records retention requirements with those applicable in other jurisdictions (December 2017 - April 2018). Policy consultations and stakeholder engagement on the proposed measures took place in fall 2020. Health Canada also published a Notice of Intent in Canada Gazette, Part I, on December 12, 2020 to inform stakeholders of the proposed policy direction, and to confirm the proposed amendments reflect stakeholders’ needs while still offering an appropriate level of protection for Canadians.
Additional engagement sessions were completed in February 2021 to better understand what potential risks to patient safety could be posed by a lower records retention period.
Health Canada will seek an exemption from pre-publication in the Canada Gazette, Part I.
The publication of the regulatory proposal in the Canada Gazette, Part II is expected in fall 2021.
Related information on clinical trials for drugs can be found on Health Canada’s website.
Departmental contact information
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Date the regulatory initiative was first included in the Forward Regulatory Plan
June 7, 2019
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