Notice: Period reduced for keeping clinical trial records for drugs and natural health products
Health Canada is reducing the retention period for clinical trial records for drugs and natural health products from 25 years to 15 years under the Food and Drug Regulations and Natural Health Products Regulations. This change takes effect on February 11, 2022. We will be updating the policies, guidance documents and other documents accordingly.
On this page
- Overview
- What sponsors need to know
- Health Canada’s own internal retention policy
- Change aligns with international regulatory partners
Overview
Health Canada has reduced the period for keeping clinical trial records for drugs and natural health products from 25 years to 15 years. This change reflects amendments to the Food and Drug Regulations and Natural Health Products Regulations. These amendments came into force on February 11, 2022 as part of the Regulations Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19.
Previously, clinical trial sponsors had to keep clinical trial records for 25 years. The new shorter period reflects their concerns about the cost and administrative burden the 25-year requirement placed on them.
What sponsors need to know
The period for keeping records starts on the date the record is created. To simplify the process, sponsors may choose to "start the clock" for keeping all study records when the trial is completed or terminated.
We are consulting stakeholders on the start date through consultations for the plan to modernize the regulation of clinical trials.
The requirement to keep records for 15 years would apply to sponsors of:
- clinical trials of all drugs and natural health products with ongoing record retention obligations prior to February 11, 2022
- any new clinical trials authorized on or after February 11, 2022
We will update documents over time to reflect the change to a 15-year record retention period.
Health Canada’s own internal retention policy
To protect people’s health and safety, we will continue to keep our own internal records in accordance with our retention policy.
Although we rarely access clinical trial records after 15 years, sometimes the need arises because of safety issues.
To protect patient safety beyond 15 years, we can stop the sale of a product and notify consumers to stop using the product based on the findings of safety assessments. Two examples of prescription drugs that were removed from the market after 15 years include Pergolide (Parkinson medication) and Dolasetron (chemotherapy).
Change aligns with international regulatory partners
The new 15-year retention requirement more closely aligns with our international regulatory partners. By reducing the burden to sponsors and aligning internationally, Canada will be a more favourable location for conducting clinical trials.