ARCHIVED Applications for COVID-19 drug and medical device clinical trials under the interim order: Notice of updated guidance documents

Notice to Reader:

We have replaced the Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19. See the regulations notice about the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.

Date published: May 3, 2021

Health Canada has updated 2 guidance documents to support Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19:

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

Purpose

The guidance documents contain information for applicants seeking authorization to conduct COVID-19 drug and medical device clinical trials under Interim Order (IO) No. 2. They also provide guidance for applicants and authorization holders of COVID-19 drug and medical device clinical trials under the repealed IO No. 1.

IO No. 2 continues to ensure that drugs and medical devices for diagnosing, treating, mitigating or preventing COVID-19 can be investigated efficiently within a clinical trial.

Interim order implications for applicants

IO No. 2 continues to facilitate the launch of COVID-19-related clinical trials. It reduces the administrative burden related to authorization and implementation without compromising the health and safety of participants and validity of trial data.

As IO No. 2 covers both drugs and medical devices, it uses the common term "clinical trial" rather than the Medical Devices Regulations term "investigational testing".

An IO authorization covers:

the sale or importation of a drug or a medical device for the purpose of the clinical trial
the conduct of the trial

This better enables flexible oversight through all stages of a trial.

The health and safety of participants in clinical trials is most important. IO No. 2 continues to provide Health Canada with flexibilities to oversee and intervene in clinical trials when required to safeguard the best interests of participants.

Flexibility to intervene includes being able to partially suspend or revoke a trial. This will allow the suspension of an arm, or treatment group, of a randomized trial, if needed. The rest of the trial would be allowed to proceed so that other participants can continue to receive ongoing therapy.

Health Canada will be able to use terms and conditions on clinical trial authorizations. These measures will only be used to ensure appropriate oversight or to manage uncertainties or risks. This flexibility may result in the authorization of a broader range of clinical trials that would otherwise not proceed.

The IO continues to reduce the administrative requirements for non-significant changes throughout the trial, with only significant changes requiring approval.

It also:

provides other ways to obtain informed consent
expands the range of applicants who are able to apply for a medical device clinical trial authorization
permits the use of a broader range of qualified investigators for drug clinical trials (broad range of qualified investigators is maintained for medical device trials)
reduces administrative requirements for trials involving new uses for existing marketed drugs

All these flexibilities will be particularly beneficial for complex trials, such as:

multi-site trials
multi-arm trials
remote trials
trials for repurposing marketed drugs or medical devices for COVID-19 uses

All other requirements for applicants continue to apply. These include requirements for the submission of applications and reporting of trial-related adverse events or medical device incidents to Health Canada. Applicants will also be obligated to ensure their drug clinical trial is conducted in accordance with good clinical practices.

What's new in IO No. 2

IO No. 2 continues the optional pathway introduced under IO No. 1 for any new drug and device clinical trial related to COVID-19 therapies. It also ensures that all authorizations, suspensions and exemptions for clinical trials issued under IO No. 1, including any terms and conditions, remain in effect by considering these to be under IO No. 2.

This also means that any applications that were outstanding when IO No. 1 was repealed would be considered as applications under IO No. 2.

Scope

The guidance documents apply to COVID-19 clinical trials for pharmaceutical and biologic drugs (including blood and blood components) and medical devices, including combination products. The documents also apply to applicants and authorization holders of COVID-19 drug and medical device clinical trials under IO No. 1.

Not included in the IO are radiopharmaceuticals (see schedule C of the Food and Drugs Act), natural health products and Class I medical devices. Please refer to the device guidance for additional information on eligible and non-eligible studies.

The existing regulations and guidance for all non-COVID-19-related clinical trials and those that are not in scope of the IO continue to apply to those trials.

Implementation

The guidance documents will be in effect for a period of 1 year from the date the Minister signed IO No. 2.

Applicants of COVID-19 drug and medical device clinical trials can apply for authorization under either:

IO No. 2
Part C, Division 5 of the Food and Drug Regulations or
Part 3 of the Medical Devices Regulations

Once applicants apply for authorization under IO No. 2, they must proceed with that pathway.

Trials not authorized under IO No. 1 and that have already started cannot be transitioned under IO No. 2. These trials must follow the requirements of the regulations under which they were originally submitted.

Contact us

If you wish to submit an application for authorization of a clinical trial under IO No. 2, please contact Health Canada. Alternatively, you may refer to the relevant guidance document for COVID-19 drug clinical trials or COVID-19 medical device clinical trials.

Please contact us at:

trials using pharmaceutical drugs: hc.oct.enquiries-requetes.bec.sc@hc-sc.gc.ca.ca
trials using biologic drugs (including blood and blood components): brdd.ora@hc-sc.gc.ca
trials using medical devices: it-ee@hc-sc.gc.ca

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2022-03-02