Forward Regulatory Plan 2019-2021: Alignment of Clinical Trial Record Retention Timelines

Title of Regulatory Initiative

Alignment of Clinical Trial Record Retention Timelines

Enabling Act

Food and Drugs Act

Description

Health Canada proposes to reduce the current record retention requirement in the Food and Drug Regulations from 25 years to a minimum of 15 years.

This regulatory initiative was identified as an early action in the Fall 2018 Fall Economic Statement.

This regulatory initiative was identified 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 better align the record retention requirement in Canada with international standards and requirements prescribed by other health regulators in other countries such as the United Kingdom, the European Union, the United States, and Australia.

Potential impacts on Canadians, including businesses

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.

Consultations

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 record retention requirements with those applicable in other jurisdictions (December 2017-April 2018).

Canadians will have the opportunity to provide further input during the consultation period following pre-publication in Canada Gazette Part I, which is expected in spring 2020.

Further information

Additional information can be requested from the Departmental contact.

Departmental contact information

Catherine Hudon
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada

Telephone: 613-946-6220
Email: catherine.hudon@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

May 27, 2019

Consult Health Canada’s acts and regulations web page for:

  • a list of acts and regulations administered by Health Canada
  • further information on Health Canada’s implementation of government-wide regulatory management initiatives

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

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