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

On this page

• Modified requirements
• Eligibility to make use of modified requirements
• Safety and efficacy
• Product labels
• Rolling review
• Pre-submission meetings
• Format and structure for filing
• Risk management plan
• Labelling
• Drug identification number and terms and conditions
• Market notification
• Transparency
• Fees

Modified requirements

PHED sponsors will have the option to follow modified requirements in subsections C.08.002(2.1) to (2.3), or C.08.003(5) to (7). To use these alternate modified requirements:

• sponsors must include a statement, in the cover letter, identifying that the purpose and conditions of use specified in the NDS or SNDS address only the public health need related to the applicable condition described in the list, and
• the submission itself must only relate to a condition described in the list

Modified requirements are only available where the submission relates to the condition on the list. For example, a submission seeking to add a new indication to an authorized PHED to treat a condition that is not included on the list cannot use modified requirements.

Modified requirements include:

• the ability to provide certain information or material later during a rolling review (C.08.002(2.3), C.08.003(7))
• an exemption from:
  • submitting detailed reports of tests made to establish the safety and clinical effectiveness of the new drug under paragraphs 08.002(2)(g) and (h), or
  • providing all of the information and material required under C.08.003(3), if the sponsor provides sufficient evidence that the benefits of the drug outweigh the risks, taking into account uncertainties as well as the public health need related to the condition on the list (C.08.002(2.1)(b),C.08.003(5)(b))
• for human drugs, exemption from being required to provide a final label mock-up if the sponsor provides a draft of the label (08.002(2)(j.1)), C.08.003(3.1)(a)(ii), or C.08.003(3.1)(b)(ii))
  • the sponsor must also include any package insert and document provided upon request that sets out supplementary information on the use of the drug (C.08.002(2.2), C.08.003(6))
• an exemption from being required under 08.002(2)(o) to conduct a brand name assessment

Health Canada expects sponsors to provide all known information about the proposed PHED at the time the submission is filed, including details regarding the:

• use
• formulation
• dosage form
• medicinal ingredient

We also expect sponsors to submit sufficient data to determine whether the submission seeks an NOC on the basis of a direct or indirect comparison to another drug.

Eligibility to make use of modified requirements

To use any of the modified requirements

• the submission itself must only relate to a condition described in the list and
• the sponsor must state in their NDS or SNDS cover letters that:
  • the NDS or SNDS is for a PHED (C.08.002(2.4)(a) and C.08.003(8)(a)), and
  • the purpose and conditions of use specified in the NDS or SNDS relate only to a condition described in the list (C.08.002(2.4)(b) and C.08.003(8)(b))

The options available in subsections C.08.002(2.1) to (2.3) and C.08.003(5) to (7) only apply if the sponsor has met the requirements outlined in subsection C.08.002(2.4) or C.08.003(8) respectively.

To make use of the option in subsection C.08.002(2.1) and C.08.003(5), the sponsor must also:

• make the statement required by paragraph 08.002(2.1)(a) and C.08.003(5)(a) and
• meet the requirement in 08.002(2.1)(b) and C.08.003(5)(b)

Sponsors should make all required statements in module 1.2.3, "Certification and Attestation Forms".

Health Canada intends to assess in screening whether the submission qualifies under subsections:

• 08.002(2.1), C.08.002(2.2), C.08.002(2.3) and C.08.002(2.4) or
• 08.003(5), C.08.003(6), C.08.003(7) and C.08.003(8)

If the PHED submission relies on a rolling modified requirement, it must also include a plan, in module 1.0.7 – General Note to Reviewer, 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 after the submission is filed. Refer to C.08.002(2.3) for an NDS and C.08.003(7) for an SNDS.

We encourage sponsors to facilitate screening by specifying in a cover letter that:

• the NDS relies on subsection 08.002(2.3) of the regulations, or
• the SNDS relies on subsection C.08.003(7) of the regulations

The list of missing information (material from (2)(e) to (k)) needs to be clearly documented in the submission.

This plan should be up-to-date and complete. The sponsor is encouraged to discuss and agree upon the plan in advance of filing the submission to Health Canada. Health Canada recommends a pre-submission meeting to discuss efficient filing strategies for changes, such as to chemistry, manufacturing and control changes.

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 the clinical and quality data will be available
• a post-market plan, which may include a risk management plan (RMP)

Key non-clinical information may be required to:

• support the safety of the PHED
• demonstrate the potential for clinical effectiveness under the proposed conditions of use

All key studies should be conducted in accordance with good laboratory practices. For more information:

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

Health Canada expects the missing information to be provided through regulatory transactions in an organized manner with clear references and analysis modules. 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

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

As per subsection C.08.002(2.5) and C.08.003(9), the modified requirements do not apply if the sponsor is seeking an NOC for a PHED on the basis of a direct or indirect comparison between the PHED (for example, a generic or biosimilar submission) and another drug. Where the submission does not meet the eligibility criteria to make use of the modified requirements, we will consider it against the standard drug submission requirements.

Safety and efficacy

The regulations were amended to allow sponsors who seek approval for a PHED to file a submission with a data package for a condition on the list. This package must contain sufficient evidence to support the conclusion that the benefits associated with the PHED outweigh the risks associated with it for the purpose and under the conditions of use recommended.

Sponsors should discuss data requirements with Health Canada before filing.

A sponsor may file a submission for a PHED without complying with the requirements set out in paragraphs C.08.002(2)(g) and C.08.002(2)(h). To do so:

• the sponsor must state that:
  • the submission is for a PHED (C.08.002(2)(2.4)(a), C.08.003(8)(a))
  • the purpose and conditions of use of the drug specified in the submission relate only to a condition described in the list C.08.002(2.4(b), C.08.003(8)(b),
• the submission must contain sufficient safety, efficacy and quality evidence to establish that the benefits of the new drug outweigh the risks (C.08.002(2)(2.1)(b)), C.08.003(5)(b))

Sponsors should make the required statement in module 1.2.3, "Certification and Attestation Forms." We encourage sponsors to specify in a cover letter that the submission relies on subsection C.08.002(2.1) or C.08.003(5) of the regulations to facilitate screening.

The Minister may impose terms and conditions on a DIN issued for a PHED where the submission included a statement made in paragraphs C.08.002(2.1)(a) or C.08.003(5)(a) as described in section C.01.014.21(1.1).

A sponsor that has a traditional data package to support the submission may choose not to rely on subsection C.08.002(2.1) or C.08.003(5). This submission would still be considered a PHED should it relate only to a condition on the list. However, the Minister would not have the authority to impose terms and conditions on the DIN at any time for such a drug.

Product labels

Subsections C.08.002(2.2) and C.08.003(6) provide human drug exemptions from the requirement in paragraphs C.08.002(2)(j.1), C.08.003(3.1)(a)(ii) and C.08.003(3.1)(b)(ii) to provide mock-up labels of the PHED. However, a submission for a PHED for human use 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.

Paragraph C.08.002(2)(j) and C.08.003(3.1)(a)(i) sets out the veterinary PHED submission requirements for a label.

Sponsors should refer to sections 3, 9 and 10 of the Food and Drugs Act as well as related provisions of the regulations to comply with the labelling requirements. Sponsors can also refer to:

• Guidance document: Labelling of pharmaceutical drugs for human use
• Guidance on veterinary drug labelling
• Guidance for market authorization requirements for COVID-19 vaccines: Labelling and post-market requirements

We encourage sponsors to contact us in advance to discuss their labelling proposals.

Sponsors should include an explanation as a 'note to reviewer' in the submission outlining the labelling approach if using the exemption in C.08.002(2.2), or C.08.003(6) for human drugs. To facilitate screening, sponsors of human drugs are encouraged to specify in a cover letter that the submission relies on subsection C.08.002(2.2) or C.08.003(6) of the regulations.

Rolling review

The amended regulations permit a submission to not contain all of the information otherwise required by section C.08.002 or C.08.003 at the time it is filed. Health Canada will begin the review using the information in the submission and will accept new evidence as it becomes available, in accordance with the plan, provided that the submission meets the requirements under:

• 08.002(2.3) (for an NDS)
• 08.003(7) (for an SNDS)

When providing the remaining missing information, the sponsor should confirm that it considers all missing information to have been provided.

A sponsor may file an NDS for a PHED without including some or any 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 April 1, 2027)
• paragraph C.08.002(2.1)(b)
• subsection C.08.002(2.2)
• corresponding material under section C.08.005.1

Similarly, a sponsor may file an SNDS without some or any of the information that is required to be included in a supplement under:

• subsection C.08.003(3) in relation to the matters in C.08003(2)(d) to (h)
• paragraph C.08.003(5)(b)
• subsection C.08.003(6)
• corresponding material under section C.08.005.1

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

• Guidance document: The management of drug submissions and applications
• Veterinary drugs - Management of regulatory submissions guidance

Health Canada will:

• review the submission to ensure it includes the detailed plan
• assess the information submitted by the sponsor
• accept and review new evidence (in accordance with the plan)

Any subsequent data or information sent after the submission has been filed is considered solicited information 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.

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 or C.08.003, and with C.08.005.1.

Learn more:

• Veterinary drugs: Management of regulatory submissions guidance
• Human drugs: Management of drug submissions and applications guidance document

Pre-submission meetings

Sponsors are encouraged to communicate regularly with Health Canada. Early and ongoing consultations with us help ensure that regulatory requirements are met.

Before filing an submission, sponsors 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
• indicate how and when you will provide the Minister with the missing information or material, if applicable (subsection C.08.002(2.3), C.08.003(7))

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

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

• Management of drug submissions and applications
• Management of regulatory submissions for veterinary drugs

For relevant contact information, consult:

• Key contacts

Format and structure for filing

To file a submission that makes use of the rolling review modified requirement, the sponsor must include all applicable forms.

For general procedures on how to file applications:

• Management of drug submissions and applications
• Management of regulatory submissions for veterinary drugs

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

• Guidance document on the preparation of regulatory activities in the eCTD format
• Organization and document placement for Canadian module 1
• Guidance document on the regulatory enrolment process (REP)

Sponsors who cannot comply with the formatting requirements should contact the Business Information Division within the Business Facilitation and Modernization Directorate for further options and guidance. Send an email to ereview@hc-sc.gc.ca.

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

• Preparation of regulatory activities in the non-eCTD format
• Regulatory enrolment process (REP)

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

Clinical information and requirements

A sponsor may submit an NDS or SNDS relying on the modified requirements in subsections C.08.002(2.1) to (2.3) or C.08.003(5) to (7), respectively. Sponsors should provide sufficient evidence to support the safety and efficacy of the PHED. This includes all available clinical trial data and the safety and efficacy summary documents.

Quality (chemistry and manufacturing) information and requirements

Under subsection C.08.002(2.3) and C.08.003(7) in the regulations, and in accordance with the plan given at the time of filing, the sponsor may provide on a rolling basis the information and material normally required under:

• paragraphs (2)(e), (f) and (m)
• 08.003(2)(d), (e) and (f)

The sponsor must specify in their plan how and when they will provide the missing information to Health Canada.

Sponsors should make sure that their plan is detailed and accurate, and discuss the plan with Health Canada before submitting it.

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

Check the list of guidance documents for help meeting our requirements.

Information and requirements for veterinary drugs

A submission for a PHED for veterinary use should include evidence of:

• quality
• animal safety
• human safety
• its efficacy in the target species

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

Risk management plan

An RMP for a PHED for human use should be submitted for consideration when assessing the safety and effectiveness of the new drug. In the case of a rolling review, the sponsor may provide the RMP to Health Canada after the submission has been filed. Submitting and updating an RMP may be required as a term and condition imposed on a PHED submission, in applicable circumstances.

The RMP should focus on the product's 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:

• describe the product's safety risks and associated uncertainties
• describe the pharmacovigilance and risk minimization activities used to identify, characterize, prevent or minimize the product's risks and uncertainties
• describe intended measures for evaluating the effectiveness of such risk minimization measures
• include relevant details such as:
  • the timing of implementation of measures
  • evaluation of measures
  • reporting, including milestones

Health Canada expects RMPs found to be acceptable following the review of the submission for a PHED to be implemented. Additional post-market requirements may, in applicable circumstances, be imposed as terms and conditions on the DIN. Examples include:

• elements of an RMP, such as implementing a specific pharmacovigilance or risk minimization measure
• a requirement to submit milestones outlined as reportable outcomes regarding a pharmacovigilance or risk minimization measure

For more detailed information on the scope, application and content of RMPs:

• Submission of risk management plans and follow-up commitments

When filling a PHED submission, the RMP should include:

• a safety specification section with a detailed description of the risks associated with the drug and the uncertainties relating to those risks
  • Risks could include important identified risks, important potential risks and missing information for the product.
  • Uncertainties could include populations where there is limited information or who were excluded from clinical trials, or adverse events of special interest.
• a pharmacovigilance plan with a detailed description of the measures that the sponsor intends to take to address and monitor the uncertainties
  • These could include the specific activities to be taken to identify and report safety issues, such as:
    • periodic reporting
    • expedited adverse reaction reporting
    • ongoing or planned post-authorization studies to quantify and characterize those risks (for example, registries and prospective cohort studies)
• a risk minimization plan with a detailed description of the measures that the sponsor intends to take to prevent or reduce the risks, including:
  • routine risk minimization measures (for example, labelling)
  • additional measures beyond those considered routine, if needed, such as:
    • educational materials for health care professionals or patients
    • a restricted access or distribution program
• a detailed description of how the sponsor intends to evaluate the effectiveness of the measures that they intend to take to prevent or reduce the risks

Note that if you have filed under the modified requirement in subsection C.08.002(2.1) or C.08.003(5), any elements of an RMP that are essential to manage the risks and uncertainties of the product could be imposed as terms and conditions and must be implemented.

A Canadian addendum that demonstrates that the RMP meets Canadian regulatory requirements must accompany the core or reference RMP.

Learn more:

• Notice of clarification to drug manufacturers and sponsors on Canadian-specific considerations in risk management plans
• Guidance Document - Submission of Risk Management Plans and Follow-up Commitments

Contact us if you have a question about the type of information required.

Labelling

Sponsors of a PHED 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.

Sponsors who file a submission of a PHED 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. In determining the nature of the warning statement, the data submitted to support the submission and any associated terms and conditions that the Minister imposes on the DIN will be taken into account.

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)) [coming into force July 1, 2025]. However, there must be an outer label that meets all regulatory requirements. Health Canada encourages sponsors to contact us to discuss their labelling proposals. If using the exemption in C.08.002(2.2) or C.08.003(6), sponsors should include an explanation as a 'note to reviewer' in the submission outlining the labelling approach.

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)) to a NDS for a PHED. The labelling requirements in C.08.003(3.1)(a)(ii) and C.08.003(3.1)(b)(ii) do not apply to a SNDS for a PHED.

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

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

For a PHED NDS for human drugs, sponsors may also file a brand name assessment package or mock-up labels after the NOC is granted. Sponsors filing a PHED SNDS may also provide mock-up labels after the NOC is granted.

If the sponsor chooses to use modified requirements in C.08.002(2.2) or C.08.003(6) for human drugs, we will request that the sponsor submit:

• a brand name assessment
• final mock-up package labels

Sponsors may provide a package that omits simulation exercises if they 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

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 sponsors 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 brand-name assessment components are not needed for the labelling of veterinary drugs.

Learn more:

• List of guidance documents (human drugs)
• Guidance on veterinary drug labelling
• Framework document for pharmaceutical, biologic and radiopharmaceutical drugs for human use only
• Safety and efficacy document for pharmaceutical, biologic and radiopharmaceutical drugs for human use only
• Quality document

Drug identification numbers and terms and conditions

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

Once Health Canada determines that the submission for the PHED complies with regulatory requirements, we will assign a DIN and issue an NOC. The Minister may at any time impose or amend terms and conditions on a DIN (C.01.014.21(1.1)) assigned for a PHED if an NOC was issued under section C.08.004 in respect of:

• an NDS or SNDS that contains the statement referred to in paragraph C.08.002(2.1)(a), C.08.003(5)(a)
• an NDS or abbreviated new drug submission (ANDS), or a supplement to either of those submissions that was approved on the basis of a direct or indirect comparison to a PHED with a submission which contained the same statement

Learn more:

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

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

Terms and conditions are a regulatory tool that gives Health Canada appropriate oversight of an authorized drug's safety, efficacy and quality throughout its life cycle. The main objective of imposing them is to ensure a favorable benefit-risk profile of a drug is retained as was determined when the drug received its authorization.

The Minister may impose terms an conditions on the DIN of a PHED in applicable circumstances. These terms and conditions may be designed to:

• optimize the benefits and reduce the risks or significant uncertainties associated with the potential to cause injury to health
• collect information to be able to continuously assess the benefits and risks, identify any changes to them and manage the significant uncertainties related to the drug's safety, efficacy or quality, or
• manage risks and significant uncertainties

Health Canada will determine, on a case-by-case basis, the terms and conditions on a drug approved through a subsequent entry submission (for example, a generic or biosimilar submission) that relied on:

• a Canadian Reference Product (CRP) with terms and conditions
• a Canadian Reference Biologic Drug (CRBD) with terms and conditions

Any existing terms and conditions imposed on an authorized COVID-19 drug will continue to apply under the regulations as necessary. The authority to impose and amend terms and conditions at any time on existing COVID-19 authorizations will continue to apply.

Submitting information to fulfill terms and conditions

Information on fulfilling terms and conditions should be submitted in accordance with Health Canada's post-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." Provide supporting documentation.

Submitting information to fulfill terms and conditions for pharmacovigilance-related activities only

Based on the required documentation, human drugs can be filed as:

• an RMP-PV
• a PBRER/PSUR-PV
• an REG-PV or
• a PA-PV

Provide supporting documentation as a standalone submission under its own control number.

For veterinary drugs, sponsors submitting information to fulfill terms and conditions for pharmacovigilance-related activities can email vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca.

Health Canada will review the documentation to determine if the conditions have been met. We will publish all terms and conditions and note if they are on-going, pending or completed. Once we are satisfied that the sponsor has fulfilled all the terms and conditions, we will indicate this in a letter and reference the original file or control number.

Market notification

Email any questions about veterinary drugs to vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca

Learn more:

• Guide to reporting drug shortages and discontinuations (human drugs)
• Management of regulatory submissions guidance (veterinary drugs)

Transparency

Health Canada will continue to communicate up-to-date information about PHEDs.

Resources for human drugs:

• COVID-19 vaccines and treatments portal
• Drug and health product submissions under review
• Drug and health product portal review decisions
• Health Canada's clinical information portal
• Drug and health product inspections database

In addition, Health Canada will continue to provide the most up-to-date approved RMPs for human PHEDs to external stakeholders upon request until the Agile RMP regulations come into force.

We will consult with sponsors before any RMP for a PHED is made public. This will provide sponsors with the opportunity to redact commercial confidential information. Following the coming into force of the RMP regulations, RMP summaries will be made publicly available in both official languages. These summaries will reflect and summarize the content of the RMP and include any Canadian-specific considerations in clear and concise plain language accessible for a wide audience.

Learn more:

• Labelling and post-market requirements section of the Guidance for market authorization requirements for COVID-19 vaccines
• Public release of clinical information
• Management of drug submissions and applications
• Management of regulatory submissions for veterinary drugs

Fees

Fees for regulatory activities related to pharmaceutical and biological drugs are charged as per the Fees in Respect of Drugs and Medical Devices Order. Submissions for a PHED may have accelerated performance standards. However, fee remittance does not apply to rolling submissions. Consequently, paragraph 6(2)(c) has been amended to extend the exception for:

• fee remittance for an NDS for a designated COVID-19 drug to an NDS for a PHED that takes advantage of rolling review under C.08.002(2.3)
• fees for an SNDS PHED that takes advantage of the option of rolling review under C.08.003(7)

Learn more:

• Fees in Respect of Drugs and Medical Devices Order
• Fees for the review of human and disinfectant drug submissions and applications
• Guidance document - Fees for the review of veterinary drug submissions and applications