Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19

In response to the ongoing need for innovative COVID-19 diagnosis, treatment, mitigation, or prevention options, Health Canada announced the approval of Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 (IO No. 2) (effective: May 3, 2021), which replaces the first Interim Order (IO No. 1) of the same name. Health Canada also published a Notice regarding updates to two guidance documents in support of IO No. 2:

• For drugs: Applications for drug clinical trials under the interim order
• For medical devices: Applications for medical device clinical trials under the interim order

To date, numerous COVID-19 clinical trials have already leveraged the flexible mechanisms provided through IO No. 1, many of which can be found in Health Canada’s searchable list of authorized COVID-19 clinical trials. As with IO No. 1, radiopharmaceuticals, natural health products, and Class I medical devices are outside the of scope IO No. 2.

IO No. 2 maintains the existing authorizations, suspensions, and exemptions for clinical trials issued under IO No. 1, which includes any terms and conditions. Under IO No. 2, Health Canada also aims to review clinical trial applications and amendments for COVID-19 drug and medical device clinical trials within 14 days, while providing modified requirements, which include:

• Reduced administrative requirements for trials involving new uses for existing marketed drugs;
• Flexibility to use a broader range of qualified investigators for drug clinical trials, specifically by expanding the range of qualified investigators for medical device trials; and
• Flexibility to obtain informed consent in new ways and run more decentralized trials.

With these flexibilities in place through IO No. 2, Health Canada hopes to join in the global effort in fostering innovation during a time when prevention and treatment strategies are needed the most, without compromising the health and safety of clinical trial participants and data validity.

Author:  Lydia To

References

1. Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 - https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/interim-order-2-clinical-trials-medical-devices-drugs.html
   
2. Applications for COVID-19 drug and medical device clinical trials under the interim order: Notice of updated guidance documents - https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/interim-order-2-clinical-trials-medical-devices-drugs/guidance-documents-notice.html
   
3. Applications for drug clinical trials under the interim order - https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/interim-order-respecting-clinical-trials-medical-devices-drugs/drug-guidance.html
   
4. Applications for medical device clinical trials under the interim order - https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/interim-order-respecting-clinical-trials-medical-devices-drugs/medical-device-guidance.html
   
5. Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19: Notice -
6. https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/interim-order-2-clinical-trials-medical-devices-drugs/notice.html 
7. Drugs and vaccines for COVID-19: List of authorized clinical trials - https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/list-authorized-trials.html