Notice of updated guidance: Applications for COVID-19 drug clinical trials under the Regulations
Health Canada has updated and renamed the guidance document that was created for the interim orders No. 1 and No. 2 for COVID-19-related clinical trials. The new name is Guidance on applications for COVID-19 drug clinical trials under the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.
Note: This notice excludes medical devices. A separate notice of intent and guidance on applications for COVID-19 clinical trials for medical devices is available:
On this page
- Purpose
- Scope
- What the Regulations mean for applicants
- What's new in the Regulations
- Implementation
- Contact us
Purpose
The Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (the Regulations) make it possible for COVID-19 medical device and drug clinical trials to continue under a flexible regulatory pathway. Sponsors may apply for authorization under this optional pathway, or under Part C, Division 5 of the Food and Drug Regulations.
The updated guidance document has information and guidance for:
- applicants seeking authorization to conduct COVID-19 drug clinical trials under the Regulations, instead of the Food and Drug Regulations
- authorization holders of COVID-19 drug clinical trials that were approved under the repealed IOs No. 1 and No. 2
Scope
The guidance document applies to COVID-19 clinical trials for pharmaceutical and biologic drugs (including blood and blood components). It also applies to authorization holders of COVID-19 drug clinical trials under IO No. 1 and IO No. 2.
For non-COVID-19-related clinical trials and those outside the scope of the Regulations, the Food and Drug Regulations, Natural Health Products Regulations and Medical Devices Regulations and related guidance continue to apply.
What the Regulations mean for applicants
The Regulations maintain all the flexibilities that were available through the repealed IOs No. 1 and No. 2. These flexibilities include:
- fewer requirements for assessing new uses of marketed drugs for COVID-19
- flexible ways to obtain informed consent for certain patients
- a broader range of qualified health care professionals to carry out drug trials
- a broader range of applicants who are able to apply for medical device trials
The reduced administrative burden that was in place under IOs No. 1 and No. 2 is also maintained.
What's new in the Regulations
The Regulations continue the optional pathway that was in place under IO No. 2 for any drug and medical device clinical trial related to COVID-19 therapies. It ensures that all authorizations, suspensions and exemptions for clinical trials issued under IOs No. 1 and No. 2 remain in effect. This includes any terms and conditions.
The short-term records retention periods required by the temporary nature of the IOs have been replaced with longer periods in the Regulations, including a 15-year retention period for clinical trials of COVID-19 drugs.
Implementation
The provisions of IO No. 2 are set to expire on May 3, 2022. They will be replaced by the Regulations, which came into force on February 27, 2022.
The Regulations maintain the flexibilities set out by IO No. 2 until the framework established through the Clinical Trials Modernization Initiative is in place.
Sponsors of COVID-19 drug clinical trials may apply for authorization under either:
- the Regulations or
- Part C, Division 5 of the Food and Drug Regulations
Once sponsors apply for authorization under the Regulations, they must proceed with that pathway.
Trials not authorized under IO No. 2 and that have already started cannot be transitioned under the Regulations. These trials must follow the regulations under which they were originally submitted.
Contact us
- For trials using pharmaceuticals drugs: oct.enquiries-requetes.bec@hc-sc.gc.ca
- For trials using biologic drugs and blood components: brdd.ora@hc-sc.gc.ca
- For trials using natural health products: nnhpd-dpsnso@hc-sc.gc.ca
- For trials using medical devices: meddevices-instrumentsmed@hc-sc.gc.ca
Related links
- Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19
- Guidance on applications for COVID-19 drug clinical trials under the Regulations
- Guidance on applications for COVID-19 medical device clinical trials under the Regulations
- Guidance document for clinical trial sponsors: Clinical trial applications
- Clinical Trials Database
- Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors
- Drugs and vaccines for COVID-19: List of authorized clinical trials
- Conducting a clinical trial for COVID-19 medical devices: List of authorized clinical trials
- Clinical trials for natural health products