Health Canada is pleased to announce they have 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.
Health Canada will be updating the policies, guidance documents and other documents accordingly.
The notice to industry and the banner announcing the change will be posted on their website.
Should you have any further questions, please do not hesitate to contact us at GCP_BPC@hc-sc.gc.ca.