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Interim Order Respecting Clinical Trials Relating to COVID-19

Interim Order Respecting Clinical Trials Relating to COVID-19

On May 23, 2020, the Minister of Health of Canada approved an Interim Order (IO) Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19. The IO aims to facilitate clinical trials for potential COVID-19 drugs and medical devices, while upholding strong patient safety requirements and validity of trial data. Under the IO, Health Canada aims to review COVID-19 related clinical trials applications within 14 days.

The Interim Order applies to:

  • new COVID-19 related drugs and medical devices that are not yet licensed in Canada or other jurisdictions
  • new COVID-19-related uses for existing drugs and devices licensed in Canada

This Interim Order does not apply to

  • radiopharmaceutical drugs
  • natural health products
  • Class I medical devices.

Requirements under the IO:

  • To sell or import a COVID-19 drug/device for the purposes of conducting a clinical trial, the applicant must submit a Clinical Trial Application (CTA) to seek Health Canada authorization prior to the initiation of the trial.
  • Before the COVID-19 drug/device can be imported or sold or before the clinical trial commences, the authorization holder must have obtained approval from the Research Ethics Board at each site
  • The clinical trial must be conducted in accordance with internationally recognized Good Clinical Practices.
  • Authorization holders must submit significant changes in respect of the drug/device being studied to Health Canada for authorization prior to implementing these changes.

Regulatory flexibilities under the IO:

  • Reduced administrative requirements for assessing the use of existing marketed products as possible COVID-19-related therapies
  • Allow alternate means of obtaining informed patient consent to facilitate virtual trials and infection control in the context of COVID-19.
    • remote written informed consent
    • non-written informed consent obtained through reading the contents of the informed consent form to the trial participant and receiving the individual’s informed consent before a witness, and subsequent attestation by the witness that the consent was given.
  • broaden the range of qualified investigators
    • expanded to include other health care practitioners, such as nurse practitioners, pharmacists and midwives
  • expand the range of applicants who are able to apply for a medical device clinical trial authorization
    • an application may be submitted by not only manufacturers and importers but also others such as clinicians, academia, contract research organization, etc.
  • Support greater decentralization of trials to multiple/remote sites
  • Facilitates a broader range of trials that may not otherwise have been authorized or allows the ability to further address uncertainties or mitigate risks.

If you or your company is interested in learning what is needed to meet the regulatory requirements or is looking to submit an application for authorization of a clinical trial under the IO, now is the time act. Quality Smart Solutions has a team of specialists who can help you. Get prepared now and contact us today to discuss how we can be your solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 13 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Cannabis, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

 

References

Applications for drug clinical trials under the Interim Order: Guidance document https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/interim-order-respecting-clinical-trials-medical-devices-drugs/drug-guidance.html

Applications for medical device clinical trials under the Interim Order: Guidance document 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