Clinical trial authorization for COVID-19

Summary#

This Order (registered June 10, 2020) brings several parts of the Budget Implementation Act, 2019, No. 1 into force one day after the Order is made. Those parts change the Food and Drugs Act to make clinical trials a distinct, regulated activity and to let the Minister of Health set up a fast, temporary pathway for COVID‑19 clinical trials.

What it does#

• Brings into force specific sections of the Budget Implementation Act, 2019, No. 1 that add new rules about clinical trials to the Food and Drugs Act.
• Adds new definitions (including “clinical trial” and “therapeutic product authorization”) and treats authorization to conduct a clinical trial as a legal requirement.
• Creates a new prohibition on conducting a clinical trial without an authorization, and lets the Minister of Health attach terms and conditions to authorizations.
• Requires that certain information about clinical trials be made public in the way and time set by the Minister.
• Gives the Governor in Council broader regulation‑making power over how clinical trials are run, how authorizations are issued, and how post‑trial safety information is reported.
• Makes breaches of these new rules subject to existing offence provisions in the Food and Drugs Act.
• Enables an interim order (an optional, expedited pathway) to be made for COVID‑19‑related drug and device trials. That interim order, if used, would last for one year unless extended.

Who's affected#

• Drug and medical device companies that develop treatments or devices for COVID‑19.
• Academic and clinical researchers who run trials.
• Sponsors and holders of existing clinical trial authorizations — they will be treated as holding a deemed authorization when these provisions come into force.
• Patients and people who might volunteer for trials, because trial approvals and public information rules could change.
• Health Canada and officials who will write and enforce the new rules.
  If anything above is unclear in scope, the source notes the immediate use is aimed at COVID‑19 trials and that the interim pathway is optional.

Why it matters#

• It creates a new, clearer legal framework for clinical trials in Canada.
• It lets regulators offer an optional, faster route to approve COVID‑19 clinical trials. That could speed up testing of potential treatments and devices.
• It also requires more public disclosure about trials and strengthens reporting of safety information.
• Because the change introduces a new prohibition on conducting trials without authorization, companies and researchers will need to follow the new authorization rules or remain on existing pathways that are explicitly exempted by the interim approach.