As of February 11, 2022, the retention period for records of clinical trials of drugs and natural health products has been reduced from 25 years to 15 years in Canada. According to Health Canada’s Notice: Period reduced for keeping clinical trial records for drugs and natural health products (the “Notice”), the change is intended to harmonize the country’s clinical trial framework with that of its international partners. It is further intended to make Canada a more attractive country in which to conduct clinical trials by reducing the administrative burden on sponsors.
Coming Into Force and Application
The amendments to the Food and Drugs Regulations and the Natural Health Products Regulations were promulgated as part of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (the “Regulations”). The Regulations were published in Part II of the Canada Gazette [PDF] on March 2, 2022, but the changes take effect on the day of registration, i.e. February 11, 2022.
Though not expressly stated in the Regulations, Health Canada’s Notice clarifies that the new retention period will apply retroactively to clinical trials for drugs and natural health products that have ongoing record retention periods (i.e. records generated in the last 15 years become subject to the new 15-year retention period while records generated before that simply no longer need to be retained). Of course, all new clinical trials authorized on or after the date of publication are also affected. Sponsors may therefore wish to review their past clinical trial agreements and update their templates going forward in order to take advantage of the reduced retention period.
However, the regulatory changes do not affect Health Canada’s internal retention policy.
Starting the Clock
The Notice further clarifies that the 15-year retention period begins on the date the record is created. However, sponsors may opt to start the retention period upon completion or termination of a trial such that the retention period for each document from the clinical trial ends at the same time.
Stakeholders can comment on the start date of the retention period during public consultations on the plan to modernize the regulation of clinical trials.
Impact on Clinical Trials for COVID-19
Interim Order No. 2 expires on May 3, 2022. They will be replaced by the Regulations published on March 2, 2022. The retention period for clinical trials of drugs that are subject to the regulations will also be 15 years.
See: Notice: Clinical trials for medical devices and drugs relating to COVID-19 regulations and Notice of updated guidance: Applications for COVID-19 drug clinical trials under the Regulations.
Special thanks to Alexandra Lemelin, Student, for her contributions to this article.