Guidance on the Food and Drug Regulations for public health emergency drugs: Preparing a submission

Submission process

The amendments to the regulations provide a mechanism for public health emergency drugs (PHED) to be authorized through a notice of compliance (NOC) based on modified requirements.

Table 1 gives an overview of the modified requirements for public health emergency drugs in the regulations.

To make use of any of the alternative requirements, the manufacturer must make the following statements in their NDS:

that the NDS is for a public health emergency drug (C.08.002(2.4)(a)) and
that the purpose and conditions of use specified in the NDS relate only to COVID-19 or a condition described in the List (C.08.002(2.4)(b))

To meet the requirements in subsection C.08.002(2.1), the manufacturer must also make the statement required by paragraph C.08.002(2.1)(a) and meet the requirement in C.08.002(2.1)(b). Manufacturers should ensure that all statements required are made in module 1.2.3, "Certification and Attestation Forms."

Table 1: Overview of modified requirements for public health emergency drug submissions

Scenario	Submission code	Available modified requirements	Terms and conditions
New public health emergency drug	NDS	C.08.002(2.1): supportive evidence C.08.002(2.2): draft label C.08.002(2.3): rolling review	Yes
Marketed drug adding additional indication for COVID-19 or a condition described in the List	SNDS	Modified requirements (as above)	Yes
Supplemental new drug submissions (SNDS) following authorization of the NDS for a PHED	SNDS	Modified requirements (as above)	Yes

Manufacturers who intend to file a submission seeking an NOC for a public health emergency drug on the basis of a comparison with another public health emergency drug are encouraged to contact us for a pre-submission meeting. Please refer to the Pre-submission meetings subsection.

Modified requirements

Manufacturers of public health emergency drugs will have the option to follow requirements as set out in subsections C.08.002(2.1) to (2.3). To make use of these alternate requirements, manufacturers must include a statement identifying that the purpose and conditions of use specified in the NDS address only the public health need related to COVID-19 or the applicable condition described in the List.

Manufacturers should ensure that all statements required are made in the cover letter and "Certification and Attestation Forms."

Modified requirements include:

ability to provide missing information or material during a rolling review (C.08.002(2.3))
exemption from submitting detailed reports of tests made to establish the safety and clinical effectiveness of the new drug under paragraphs C.08.002(2)(g) and (h)
- however, the manufacturer must provide sufficient evidence that the benefits of the drug outweigh the risks, taking into account uncertainties as well as the public health need related to COVID-19 or to the condition on the List (C.08.002(2.1)(b))
exemption from being required under C.08.002(2)(j.1) to provide final mock-up if the manufacturer provides a draft of the label
- submission must also include any package insert and document provided upon request that sets out supplementary information on use of the drug (C.08.002(2.2))
exemption from being required under C.08.002(2)(o) to conduct an assessment as to whether there is a likelihood the new drug will be mistaken for another drug due to a resemblance between the brand names
- commonly referred to as a brand name assessment

The options available in subsections C.08.002(2.1), C.08.002(2.2) and C.08.002(2.3) only apply if the manufacturer has met the requirements outlined in subsection C.08.002(2.4).

Health Canada intends to assess whether the submission qualifies under subsections C.08.002(2.1), C.08.002(2.2), C.08.002(2.3) and C.08.002(2.4) in screening.

In accordance with subsection C.08.002(2.5), the amended regulations do not apply if the manufacturer is seeking an NOC for a public health emergency drug on the basis of a direct or indirect comparison between the public health emergency drug and another public health emergency drug (for example, a generic or biosimilar submission).

Safety and efficacy: C.08.002(2.1) as an alternative to C.08.002(2)(g) and C.08.002(2)(h)

The regulations were amended to allow manufacturers who seek approval for a public health emergency drug to file a submission with an alternative data package for a COVID-19 drug or a condition that is on the List.

As more products emerge to address COVID-19 or a condition on the List, manufacturers should discuss data requirements with Health Canada before filing. A data package based on C.08.002(2.1) may only be appropriate in some circumstances.

Following discussion with Health Canada, a manufacturer may file an NDS for a public health emergency drug without complying with the requirements set out in paragraphs C.08.002(2)(g) and C.08.002(2)(h). To do so:

the manufacturer must state that the NDS is for a public health emergency drug (C.08.002(2)(2.1)(a))
the NDS must contain sufficient safety, efficacy and quality evidence such that the benefits of the new drug outweigh the risks (C.08.002(2)(2.1)(b))
Health Canada also considers in addition to the evidence:
- the uncertainties relating to the benefits and risks
- the public health need relating to COVID-19 or the condition on the List

Manufacturers should make the required statement in module 1.2.3, "Certification and Attestation Forms." Manufacturers are encouraged to specify in a cover letter that the NDS relies on subsection C.08.002(2.1) of the regulations to facilitate processing.

A manufacturer who relies on C.08.002(2.1) to provide evidence of safety and efficacy will be subject to any terms and conditions that might be imposed on a DIN issued for the public health emergency drug. Refer to section C.01.014.21(1.1). In the context of the public health need related to COVID-19 or a condition on the List, the manufacturer is required to include in the NDS sufficient safety, efficacy and quality evidence showing that the drug's benefits outweigh the risks. Terms and conditions on the DIN may be imposed as needed, including to require the manufacturer to address and/or manage risks and uncertainties after authorization.

A manufacturer that has a substantive data package to support the NDS may choose not to rely on subsection C.08.002(2.1).

For more information, consult the following guidance documents:

Product labels

Subsection C.08.002(2.2) provides for exemption from the requirement in paragraph C.08.002(2)(j.1) to provide a mock-up of labels of the public health emergency drug.

However, the submission must contain a draft of every label to be used with the new drug. This includes any package insert and any document that sets out supplementary information on the use of the new drug.

Health Canada will accept text-only labels and/or mock-up labels (if available). Sponsors should refer to sections 3, 9 and 10 of the Food and Drugs Act as well as related provisions of the regulations to ensure they are complying with the labelling requirements. You may also refer to the following guidance documents for more information:

Sponsors are also encouraged to contact us in advance to discuss their labelling proposals. If utilizing the exemption in C.08.002(2.2), sponsors should include a rationale and 'note to reviewer' in the submission outlining the labelling approach.

To facilitate processing, manufacturers are encouraged to specify in a cover letter that the NDS relies on subsection C.08.002(2.2) of the regulations.

Rolling review

Health Canada recognizes that the submission may not contain all of the information otherwise required by section C.08.002 at the time it is filed. Health Canada will begin our review using the information submitted by the manufacturer and accept new evidence as it becomes available. When providing the balance of the remaining missing information, the sponsor should confirm that it considers all missing information to have been provided.

A manufacturer may file an NDS for a new public health emergency drug without including some of the data otherwise required under:

paragraphs C.08.002(2)(e) to C.08.002(2)(k), C.08.002(2)(m), and C.08.002(2)(n)
paragraph C.08.002(2)(p) (coming into force on one-year anniversary of the date on which the regulations are registered in Canada Gazette, Part II)
paragraph C.08.002(2.1)(b)
subsection C.08.002(2.2) or
section C.08.005.1

Similarly, a sponsor may file an SNDS without some of the information that is required to be included in a supplement under subsection C.08.003(3) and, if applicable, corresponding information that is required to be included in the supplement under section C.08.005.1.

To file an NDS for rolling review, the manufacturer must include all applicable forms and other administrative components. The NDS must also include a plan identifying the missing parts of the submission. This plan must specify how and when the missing information or material will be provided to the Minister during the review period. Refer to C.08.002(2.3).

The plan should be up-to-date and complete. The manufacturer should discuss and agree upon the plan in advance of the submission to Health Canada. Some elements of the plan may be more appropriate to file as an SNDS following approval of the NDS, rather than as part of a rolling review. Health Canada recommends a pre-submission meeting to discuss efficient filing strategies for changes, such as chemistry, manufacturing and control changes. Health Canada expects the missing information to be provided in a small number of regulatory transactions.

Manufacturers are encouraged to specify in a cover letter that the NDS relies on subsection C.08.002(2.3) of the regulations to facilitate processing.

As with other NDSs under Division 8, the filing date refers to the date that:

the NDS is deemed administratively complete by Health Canada
all the elements and forms required for processing are completed and submitted to Health Canada

This is typically the same day the regulatory activity is received by Health Canada.

The filing date may differ from the date of original receipt if the submission is considered to be administratively incomplete at that time. Any missing data or information that is subsequently provided during a rolling review will be considered solicited information under the NDS and will not change the filing date of the submission.

The process for establishing a filing date has not changed from the standard process outlined in the following guidance documents:

Sufficient information must be submitted within a reasonable timeframe. The Minister reviews the NDS based on the requirements and makes a decision, as per section C.08.004 of the regulations.

The plan should contain:

a list of the non-clinical, clinical and quality data to be provided (planned and in progress)
a timeframe for when this clinical and quality data will be available
a timeframe for when this clinical and quality data will be filed for review

If the missing information outlined in the plan will be submitted through multiple regulatory transactions, the plan must clearly specify what information will be contained in each regulatory transaction. For example:

regulatory transaction A will be submitted on DD/MM/YYYY and contains results from studies XX, YY and ZZ
regulatory transaction B will be submitted on DD/MM/YYYY and contains results from studies MM, NN and OO

Pre-submission meetings provide an opportunity to discuss the PHED application plan in detail. These meetings should be used to:

establish submission content and timelines
determine the data that will be submitted when the submission is filed
determine the data that will be provided at a later date

The cover letter should refer to the plan. If changes are required to labelling to reflect the new information, annotated and clean copies of the drug labels should be included.

Health Canada will:

review the submission to ensure it includes the detailed plan
assess the information submitted by the manufacturer
accept new evidence as it becomes available until the review has been completed

Any subsequent data or information sent after the submission has been filed is considered solicited information under the NDS if the data or information is provided according to the plan or in response to Health Canada's request. Information or data provided otherwise may be considered unsolicited information. Refer to section 14 of the Management of Drug Submissions and Applications Guidance Document. There may be situations where an update to the plan is appropriate. We will assess these on a case-by-case basis. However, changes in the timing or content should be avoided if possible as they will impact the review timeline and efficiency.

Health Canada will not issue an NOC unless the Minister is satisfied that the NDS complies with the requirements of section C.08.002.

Regulatory activity and transaction details for public health emergency drugs

As noted, modified requirements introduced through amendments to the regulations are available for NDS and SNDSs. The "NDS CV" submission code is the code used for current submissions for NDSs that use any of the provisions in subsections C.08.002(2.1), C.08.002(2.2) or C.08.002(2.3) of the regulations. The manufacturer must select the "NDS CV" submission code in the appropriate Regulatory Enrolment Process (REP) regulatory transaction template when submitting their NDS. "NDS CV" submission code is described as "Drug submission with modified requirements for public health emergency drugs."

To file an NDS that does not benefit from any of the modified requirements mentioned in the previous 3 subsections (on safety and efficacy, rolling review, product labels), a manufacturer must select the regular NDS submission code when submitting their NDS.

Pre-submission meetings

Manufacturers are encouraged to communicate regularly with Health Canada. Early and ongoing consultation(s) with us help ensure that regulatory requirements are met.

Before filing an NDS, manufacturers are encouraged to request a pre-submission meeting to discuss all aspects of their submission. At this meeting, we will expect you to describe your submission plan and indicate how and when you will provide the Minister with the missing information or material, if applicable (subsection C.08.002(2.3)).

To request a pre-submission meeting with the appropriate directorate, consult the guidance documents on the:

For relevant contact information, please refer to key contacts.

Format and structure for filing

For general procedures on how to file applications, please also refer to the guidance documents on the:

Submissions for human drugs should be formatted, structured and filed as outlined in the:

Manufacturers who cannot comply with the formatting requirements may contact the Office of Submissions and Intellectual Property for further options and guidance. Please send an email to ereview@hc-sc.gc.ca.

Submissions for veterinary drugs should be formatted, structured and filed as outlined in the following guidance documents on the:

Manufacturers who cannot comply with the formatting requirements may contact the Veterinary Drugs Directorate by email at vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca.

Content and requirements for filing

The sponsor must include all the data they rely on to support their submission in the NDS. The sponsor should consult with Health Canada at a pre-submission meeting before filing.

For both the non-clinical and clinical information package, you may not need to include as much information at the time of filing as you do for a data package in a typical drug submission. This is balanced by additional information, which is to be provided as part of the rolling review.

Non-clinical information and requirements

Key non-clinical information may be required to:

demonstrate the potential for clinical effectiveness under the proposed conditions of use
support the safety of the public health emergency drug

All key studies should be conducted in accordance with good laboratory practices.

For more information, consult the following guidance document for human drugs:

Non-clinical laboratory study data supporting drug product applications and submissions: Adherence to good laboratory practice

Clinical information and requirements

A manufacturer may submit an NDS relying on the modified requirements in subsections C.08.002(2.1) to (2.3). Sufficient evidence should be provided to support the safety and efficacy of the public health emergency drug. This includes all available clinical trial data and the safety and efficacy summary documents.

For more information on COVID-19 products, refer to the following guidance documents:

Quality (chemistry and manufacturing) information and requirements

For further guidance on meeting submission and information requirements, consult the list of guidance documents.

Under subsection C.08.002(2.3) in the regulations, the manufacturer may provide the information and material normally required under paragraphs (2)(e), (f) and (m) on a rolling basis. The manufacturer must specify in their plan how and when they will provide the missing information to Health Canada.

Manufacturers should make sure that their plan is detailed and accurate, and discuss the plan with us before submitting it.

We will review the timing proposed in the plan as well as the chemistry and manufacturing information.

For more information on COVID-19 products, refer to the following guidance documents:

Comparative submissions for subsequent entry drugs

The regulations do not allow comparative submissions to be filed while benefitting from any of the modified requirements, even where consent from the reference product manufacturer is provided.

Subsection C.08.002(2.5) excludes the application of subsections C.08.002(2.1), (2.2) and (2.3). Where subsection C.08.002(2.5) applies, the submission will be assessed against regular criteria in screening.

Information and requirements for veterinary drugs

A new drug submission for a public health emergency drug for veterinary use should include evidence of its efficacy in the target species, animal safety, human safety and quality.

For drugs used in a food-producing animal, information should be provided on the safety of drug residues in meat and other food products from the treated animal intended for human consumption.

Risk management plan

Until such time that the requirement to provide a risk management plan (RMP) for an NDS comes into force (for exmaple, C.08.002(2)(p)), RMPs for public health emergency drugs for human use will be required through the use of terms and conditions. In the case of a rolling review, the sponsor may provide the RMP to Health Canada after the submission has been filed.

The RMP should focus on the product's updated safety risks and uncertainties in the context of public health emergency use to ensure that:

the benefit-risk profile of the product is managed optimally during its life cycle
knowledge gaps at the time of authorization are described and risks are further quantified and characterized over time

It should:

outline the product's safety risks and uncertainties related to the purpose and conditions of use related to COVID-19 or a condition on the List
outline the pharmacovigilance activities and risk minimization activities used to identify, characterize, prevent or minimize risks
contain an evaluation of the effectiveness of such risk minimization measures

To ensure the safe and effective use of a product, additional post-market requirements may be imposed as a term or condition on the DIN. For example, elements of an RMP such as additional measures to minimize risk or uncertainty might become terms and conditions if they meet the criteria.
For information on the scope and application of RMPs, please refer to the following guidance document:

Submission of risk management plans and follow-up commitments

For public health emergency drugs submitted for authorization, the RMP should include the following:

safety specification section with a detailed description of the risks associated with the drug and the uncertainties relating to those risks (for example on the identified risks, potential risks and missing information for the product) such as, special populations where there is limited information or who were excluded from clinical trials
pharmacovigilance plan with a detailed description of the measures that the manufacturer intends to take to address and monitor the uncertainties, such as the specific activities to be taken to identify and report safety issues, including expedited adverse reaction reporting, periodic reporting and ongoing/planned studies to quantify and characterize those risks (for example, registries, prospective cohort studies)
risk minimization plan with a detailed description of the measures that the manufacturer intends to take to prevent or reduce the risks, including routine risk minimization measures (for example, labelling) and additional measures beyond those considered routine (such as educational materials for health care professionals or patients, or a restricted access or distribution program), if needed
a detailed description of how the manufacturer intends to evaluate the effectiveness of the measures that they intend to take to prevent or reduce the risks
a summary of the plan's contents, in English and in French

An RMP that has been reviewed and accepted as part of the submission for a public health emergency drug is expected to be implemented. If the manufacturer filed under the requirement in subsection C.08.002(2.1), any elements of an RMP that are essential for the safe and effective use of the product could be identified as terms and conditions and must be implemented.

When section C.08.002(2)(p) of the regulations is in force, sponsors or Market Authorization Holders must submit an RMP summary as part of their submission or RMP updates. The format of the RMP summary will be specified in the Submitting risk management plans guidance document that will support section C.08.002(2)(p).

A Canadian addendum that demonstrates that the RMP meets Canadian regulatory requirements must accompany the core RMP. Information on these requirements is provided in the following guidance documents and recent notice:

If you have a question about the type of quality, safety and effectiveness information required, please contact the appropriate directorate within Health Canada. Please refer to the key contacts for relevant contact information.

Labelling

Manufacturers of a public health emergency drug must comply with all applicable labelling requirements in the Food and Drugs Act and parts A and C of the regulations.

Existing regulatory provisions on the labelling of veterinary drugs also apply.

Manufacturers who file an NDS for a public health emergency drug using the modified requirements may be asked to include a warning statement on the inner and outer labels. This statement may be displayed on any panel. The data submitted to support the NDS and any associated terms and conditions that the Minister places on the DIN will dictate this.

Drug products that are packaged in special containers or ones that are too small to accommodate the inner label requirements outlined in the regulations may contain abbreviated labelling (subsection C.04.009(6)). But there must be an outer label that meets all regulatory requirements. Sponsors are encouraged to contact Health Canada to discuss their labelling proposals. If using the exemption in C.08.002(2.2), sponsors should include a rationale and 'note to reviewer' in the submission.

The plain language labelling requirements for mock-up labels and a brand name assessment package do not apply (paragraphs C.08.002(2)(j.1) and C.08.002(2)(o)).

While exempt from these requirements, manufacturers are strongly encouraged to complete and submit a brand name assessment package and to provide mock-up labels:

at the time of NDS filing (if available) or
at the earliest time after the NDS is filed

Manufacturers may also file these materials after the NOC is granted.

Health Canada may apply labelling terms and conditions as necessary. We will request that the sponsor submit a brand name assessment and final mock-up package labels at an agreed-upon time if the sponsor chooses to use the exemption in C.08.002(2.2).

Manufacturers who are unable to provide a complete brand name assessment package at the time of filing or at the earliest time after the NDS is filed may provide a package where simulation exercises are omitted.

The update to Canadian specific labels (including when final mock-ups are to be provided) will continue to be assessed based on the global supply and public health emergency situation. Health Canada will work with manufacturers to develop an appropriate timeline to:

submit the labelling materials to support their market authorization
transition to the Canadian labelling at a point when the global supply and public health situation will make this possible

Plain language labelling and Look-alike Sound-alike components are not needed for the labelling of veterinary drugs.

Consult the list of guidance documents for further guidance on labelling.

Filing a supplement to an NDS for a public health emergency drug

A manufacturer of a public health emergency drug may file an NDS under section C.08.002 of the regulations. Once the manufacturer receives an NOC for the public health emergency drug, they may file a supplement to that new drug submission (SNDS) for any changes post-NOC.

Filing a supplement to an NDS for a public health emergency drug depends on the situation. The SNDS relies on the original modified requirements on the NOC. Discuss with Health Canada before filing.

Consult the following guidance documents on post-notice of compliance (NOC) changes:

Notice of compliance for a public health emergency drug

For Health Canada to issue a notice of compliance (NOC) (C.08.004) for the sale of a public health emergency drug, the NDS must meet the requirements of section C.08.002.

For drugs relying on the modified requirements in subsection C.08.002(2.1), the NDS must contain sufficient evidence to support the conclusion that the drug's benefits outweigh the risks when used as indicated. The evidence takes into consideration the uncertainties around the drug in the context of the public health need related to COVID-19 or the condition on the List.

Drug identification number

Once an NOC is issued for a public health emergency drug, Health Canada assigns a drug identification number (DIN).

For more information on DINs, refer to the:

Guidance document on the regulatory requirements for drug identification numbers (DINs)

Terms and conditions on a DIN pertaining to a public health emergency drug

A term and condition is an obligation that the Minister may impose on the DIN of a drug for an authorized indication, at anytime, in which the holder of a drug authorization is obligated to conduct an activity with respect to that drug. The main purpose of a T&C is to optimize the benefits and manage risks and uncertainties associated with the safety, efficacy and/or quality of a drug. Examples of potential terms and conditions can include:

specific pharmacovigilance and risk mitigation and management measures
additional quality information
confirmation of effectiveness

The Minister may at any time impose or amend terms and conditions on a DIN (C.01.014.21(1.1)) assigned for a public health emergency drug if an NOC was issued under section C.08.004 in respect of:

a new drug submission that contains the statement referred to in paragraph C.08.002(2.1)(a), or a supplement to such a submission
an NDS, ANDS or supplement to either submission, that does not rely on the statement referred to in paragraph C.08.002(2.1)(a) but was filed on the basis of a direct or indirect comparison to another public health emergency drug submission that did

Terms and conditions will be determined on a case-by-case basis for drug submissions that have relied on a comparator drug where terms and conditions have been imposed. Any post-market commitments for a reference product may also be imposed on DINs for NOCs issued on the basis of a comparison, if appropriate.

Health Canada will discuss the terms and conditions with the sponsor before imposing or amending them. All terms and conditions are enforceable under section 21.7 of the act.

Note: New authorities respecting terms and conditions that can be placed on any drug that has been assigned a DIN will come into force on the one-year anniversary of the day on which the Regulations Amending Certain Regulations made under the Food and Drugs Act (Agile Licensing) are registered.

For more information, refer to the:

Terms and conditions guidance for human and veterinary drugs

Submitting information to fulfill terms and conditions

Information on the fulfilment of terms and conditions should be submitted in accordance with Health Canada's post-notice of compliance (NOC) changes guidance documents with an accompanying cover letter. These can be filed as an SNDS or as a notifiable change, as appropriate. The subject line of the cover letter should state "Solicited information, fulfilling terms and conditions for public health emergency drug." Supporting documentation is to be provided. In some cases, information may be submitted as solicited information under the corresponding submission file/control number or as a separate pharmacovigilance submission.

Health Canada will review the documentation to determine if the conditions have been met. All terms and conditions will be published and Health Canada will note if they are on-going, pending or completed. Once we are satisfied that the manufacturer has complied with all the terms and conditions, we will indicate this in a letter and reference the original file/control number.

Market notification

The manufacturer of a public health emergency drug authorized under the regulations must notify Health Canada when they first sell the public health emergency drug under an NOC. The manufacturer must complete, sign, date and return the Health Canada-issued drug notification form (DNF) within 30 days of the date of the first sale. All pages of the DNF must be returned to us.

Our drug product database will indicate the DIN as "approved" until the manufacturer submits a completed DNF, at which point the DIN will be "marketed."

If the manufacturer did not file mock-up labels during review, the manufacturer should submit final mock-ups or final printed labels when the public health emergency drug is marketed or launched.

For more information on market notifications or notifications for the 'interruption of sale,' consult the:

Guidance document on the regulatory requirements for drug identification numbers (DINs)

Changes in product ownership, mergers and buyouts or licensing agreements

Submissions proposing administrative changes should be filed within administrative (abbreviated) new drug submissions ((A)NDS).

If sponsors are proposing labelling changes along with the proposed administrative changes, they must file these changes within an (A)NDS 'labelling only' to obtain Health Canada authorization. They must do so before making any changes to labelling materials on the market.

Refer to the following guidance document for more information:

Administrative processing of submissions and applications involving human or disinfectant drugs

Notification of discontinuation of sale

The manufacturer of a public health emergency drug must submit the notification of discontinuation of sale to Health Canada within 30 days after the public health emergency drug is permanently discontinued in Canada. The date of discontinuance is when the manufacturer last sells their drug, not when it is last sold at retail.

For information and general procedures on notification of discontinuance, authorization holders should consult the:

Guidance document on the regulatory requirements for drug identification numbers (DINs)

For more information on additional requirements for reporting a discontinuance of sale, refer to the:

Guide to reporting drug shortages and discontinuations

Transparency

Health Canada will continue to communicate up-to-date information about public health emergency drugs under the amended Food and Drug Regulations.

You can find the following information online:

COVID-19 product-related information, such as terms and conditions and their status, can be viewed on the COVID-19 vaccines and treatments portal and the drug and health product register
submissions for public health emergency drugs that have been accepted for review in the lists for drug and health product submissions under review
regulatory decision summaries (RDS) and summary basis of decision documents (SBDs) for public health emergency drugs for the condition on the List of Conditions that Threaten Public Health in Canada (List) are in the drug and health product register
clinical information used to seek approval of public health emergency drugs for COVID-19 or the condition on the List can be viewed on Health Canada's clinical information portal
drug inspection outcomes and measures in the drug and health product inspections database
summaries of risk management plans, providing the sponsor or market authorization holder's specified measures for pharmacovigilance and risk minimization

In addition, Health Canada will continue to provide the most up-to-date approved RMPs for public health emergency drugs in their entirety to external stakeholders upon request. We will consult with sponsors before any risk management plan for a public health emergency drug is made public.

For more information, please consult the:

Performance standards

Health Canada aims to prioritize submissions for public health emergency drugs. Drug submissions will be prioritized and reviewed to reflect the public health need.

The time required to review a submission will depend on the submission itself, the volume of data to be assessed and the ability of the manufacturer to submit the data as per the plan, where applicable. Published performance standards will apply to submissions related to public health emergency drugs, other than submissions related to COVID-19 undergoing a rolling review.

For more information, refer to the following guidance documents on the:

Fees

Fees for regulatory activities related to human drugs (pharmaceutical and biological) are charged as per the Fees in Respect of Drugs and Medical Devices Order.

Submission fees

Once a drug has received an NOC under the regulations, the existing Drug Right To Sell (DRTS) fee will apply.

Existing evaluation fees will be charged for public health emergency drug submissions filed under the regulations.

Please consult the following guidance documents:

Submissions with fees have associated performance standards. Penalties may apply. Published performance standards will apply, but it's expected that most public health emergency drug submissions will be managed and reviewed before the performance standard deadline.

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Date modified:: 2022-12-16

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