COVID-19 Clinical Trials Regulations

Summary#

The federal government made the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (registration SOR/2022-18) to keep a faster, flexible pathway for COVID-19 clinical trials in place. The rules keep the emergency flexibilities that were in the earlier interim orders and also shorten how long drug trial records must be kept from 25 years to 15 years.

What it does#

• Creates an optional authorization pathway for clinical trials of drugs and medical devices used for the diagnosis, treatment, mitigation or prevention of COVID‑19. This continues the flexibilities from the interim orders that were used during the pandemic.
• Lets sponsors import or sell a COVID‑19 drug or a COVID‑19 medical device for testing, and lets Health Canada decide whether to issue, amend, suspend or revoke those authorizations.
• Carries forward earlier interim-order approvals and applications so ongoing trials are not interrupted (transitional rules for Interim Order No. 2, made May 3, 2021 and published May 22, 2021).
• Keeps or introduces these practical flexibilities:
  • Broader list of who can be a “qualified investigator” (so, for example, some non‑physician health professionals may lead drug trials in certain cases).
  • Investigators (not just manufacturers/importers) can apply to run device trials.
  • Two alternate ways to get informed consent when in‑person or written consent is not possible: remote written consent and witnessed non‑written consent.
  • Ability for the Minister to attach terms and conditions to authorizations and to partially suspend or revoke parts (for example, a single arm) of a trial.
• Adds reporting, labelling and record‑keeping rules aimed at safety and traceability:
  • Device incidents must be reported to Health Canada within 10 days of awareness.
  • Serious unexpected adverse drug reactions must be reported within 15 days, or within 7 days if fatal or life‑threatening.
  • Labels must state that the product is investigational and list basic identifying and safety information in English and French.
• Changes records retention:
  • Clinical trial records for drugs and natural health products are reduced from 25 years to 15 years.
  • Distribution records for medical devices must be kept for the longer of the device’s projected useful life or 2 years after the holder took possession in Canada.
• Amends the Food and Drug Regulations and the Natural Health Products Regulations to reflect the new 15‑year retention period.

Who's affected#

• Clinical trial sponsors (drug companies, device manufacturers, independent investigators).
• Hospitals, clinics and research centres that host COVID‑19 trials.
• Qualified investigators and other health professionals who run or take part in trials.
• Research ethics boards that review and approve trial protocols.
• Trial participants and patients in Canada (because the rules shape how trials are run and supervised).
• Health Canada, which continues to review, monitor and inspect these trials.

Why it matters#

• It prevents disruption to COVID‑19 clinical trials that were already underway under earlier emergency rules. That keeps ongoing research and patient access to trial treatments steady.
• The pathway makes it easier to start and run multicentre and remote trials (for example, in rural or Northern communities) by widening who can lead trials and by allowing remote consent.
• Shortening the records‑retention requirement from 25 years to 15 years lowers long‑term storage and administrative costs for sponsors and sites. Health Canada’s analysis estimated annual savings in the range of about $4,240,000 to $8,880,000, and larger cumulative savings over time (estimates in the regulatory statement include retrospective and ongoing savings).
• The rules keep oversight tools (reporting duties, labelling, terms and conditions, and the power to suspend or revoke authorizations) so participant safety and data integrity remain protected.
• The changes are temporary in spirit: the regulations are intended to stay in place until a broader clinical‑trials modernization is implemented.