Conducting a COVID-19 drug and vaccine clinical trial
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Clinical trial regulations
Clinical trials are studies authorized by Health Canada that investigate the safety and efficacy of a drug or vaccine that:
- exists but is to be used for another purpose or
- is not yet available in Canada
Specifically, clinical trials examine the risks and benefits of a drug or vaccine.
Sponsors must apply to conduct a clinical trial in Canada.
For drug and vaccine clinical trials not related to COVID-19, existing regulations and processes still apply.
Applying to conduct a clinical trial for COVID-19 purposes
Health Canada is prioritizing the review of all COVID-19-related clinical trial applications and has already authorized a number of trials.
Sponsors of COVID-19-related drug and vaccine clinical trials can choose between 2 different processes:
- existing process outlined in the Food and Drug Regulations or
- process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19
On May 3, 2021, the Minister of Health signed a second interim order for clinical trials for medical devices and drugs related to COVID-19. The new interim order replaces the original signed on May 23, 2020, and continues to support the optional pathway to facilitate clinical trials for potential COVID-19 drugs and medical devices.
The new interim order continues to streamline the investigation of potential therapies and facilitates broader access for Canadians to COVID-19 related investigational drugs and medical devices. An interim order is one of the fastest mechanisms available to address large-scale public health emergencies, without following the usual regulatory process.
Under the interim order, Health Canada is reducing the administrative burden for sponsors applying to conduct a COVID-19 clinical trial, while maintaining patient safety and the validity of trial results. It is also introducing flexibility by expanding the types of health care professionals who can conduct a clinical trial. Further information can be found in the interim order notice.
Sponsors may apply to Health Canada for authorization to conduct a COVID-19 clinical trial.
The drug or vaccine in question must be:
- an existing, marketed product(s) in Canada to be used as COVID-19 treatments or
- new COVID-19 vaccines and treatments currently under development
- For enquiries about clinical trials for COVID-19 vaccines and biologic drugs, please contact firstname.lastname@example.org.
- For enquiries about clinical trials for COVID-19 pharmaceutical drugs, please contact OCT_BEC_Enquiries_Enquetes@hc-sc.gc.ca.
We are expediting discussions with sponsors that have products in development and sufficient pre-clinical data.
For information on clinical trials for COVID-19 medical devices, please visit our clinical trials for medical devices page.
- What we heard report: Records retention consultations related to the clinical trials interim order transition regulations
- Guidance for market authorization requirements for COVID-19 drugs
- Notice for industry: Ensuring predictability for interim orders relating to COVID-19
- Guidance for market authorization requirements for COVID-19 vaccines
- Management of clinical trials during the COVID-19 pandemic: Notice of clinical trial sponsors
- COVID-19 health products industry
- COVID-19: For health professionals
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