Ensuring predictability for COVID-19 clinical trials and proposal for clinical trials records retention: Notice to stakeholders
The purpose of this notice is to advise stakeholders that Health Canada is proposing to:
- maintain the flexibilities and regulatory oversight provided by the Interim order respecting clinical trials for medical devices and drugs relating to COVID-19 until at least the fall of 2021
- bring forward regulatory amendments that would allow the flexibilities under the Interim Order to continue after the fall of 2021
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The interim order (IO) introduced on May 23, 2020, provides another pathway to facilitate clinical trials for potential COVID-19 drugs and medical devices, while upholding strong patient safety requirements and validity of trial data.
The IO expires on May 23, 2021, at which time authorizations for clinical trials issued under the IO will end. In light of the ongoing COVID-19 pandemic, there’s a need for sponsors of clinical trials for urgent drugs and devices used to diagnose, treat, mitigate or prevent COVID-19 to continue their work. Thus, Health Canada proposes to maintain the flexibilities and regulatory oversight provided by the IO until at least the fall of 2021.
We’re also proposing to bring forward regulatory amendments that would allow the flexibilities under the IO to continue after the fall of 2021. Sponsors will be able to continue conducting clinical trials authorized under the IO as well as use this other pathway for new or later-phase COVID-19 clinical trials.
The proposed regulatory amendments will also:
- maintain patient safety while broadening access to these trials
- support the development of safe and effective therapies, yet through flexible measures will reduce the overall impact on the health care system
- contribute to ensuring further regulatory predictability to sponsors engaged in these important clinical trials
The proposed regulatory amendments will have minimal changes in relation to the IO. The only substantive change is to extend the records retention requirement beyond the duration of the IO. For IO-authorized drug clinical trials, Health Canada is proposing to set most records retention requirements to 15 years. For medical devices, we’re proposing to align records requirements with those outlined in the Medical Devices Regulations. Neither the IO nor these proposed transition regulations would apply to radiopharmaceutical drugs and Class I medical devices.
Health Canada is also proposing to reduce most 25-year records retention requirements to 15 years for trials authorized through normal regulatory pathways. This would apply to drugs (excluding radiopharmaceuticals) as well as natural health products under the Food and Drug Regulations and Natural Health Products Regulations. Health Canada is considering certain exceptions to this proposal.
Health Canada will consult with interested industry stakeholders, health system partners and other government departments on the proposed regulations. We will be holding a webinar and teleconference in each official language in December 2020. Written comments are also welcome by January 25, 2021.
Once stakeholder input is considered, we will publish the transition regulations in the Canada Gazette and revised guidance.
For more information or to provide comments about this notice, please email us at firstname.lastname@example.org.
For more information on the proposed records retention requirements, please email us at email@example.com.
- Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19
- Applications for drug clinical trials under the Interim Order: Guidance document
- Applications for medical device clinical trials under the Interim Order: Guidance document
- Guidance document for clinical trial sponsors: Clinical trial applications
- Applications for medical device investigational testing authorizations – guidance document
- Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors
- Ensuring predictability for interim orders relating to COVID-19: Notice to stakeholders
- Clinical trials in Canada
- Health Canada’s clinical trials database
- Drugs and vaccines for COVID-19: List of all COVID 19 clinical trials authorized by Health Canada
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