Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: Submission scenarios, reference documents and key contacts
On this page
Submission scenarios
Please refer to Table 1 in this guidance document for a summary of submission scenarios.
Scenario 1
COVID-19 drug is authorized under ISAD IO (authorization was not suspended or revoked) and a submission is subsequently filed under the Food and Drug Regulations for that drug
Manufacturers would file an NDS under Division 8 of the Regulations. The submission must include the same data as was included in the ISAD IO application, along with any necessary updates. This can include new evidence that was not available when the application was filed under the ISAD IO. Manufacturers would outline in a summary the changes to the application compared to the ISAD IO filing.
To maintain the ability to sell the COVID-19 drug authorized under ISAD IO, the NDS must be filed:
- within 90 days following coming into force of the amendments, if the drug was authorized under the ISAD IO before the amendments came into force or
- 90 days following issuance of an authorization under the ISAD IO, if the drug was authorized after the amendments came into force
Manufacturers can continue selling the COVID-19 drug under the ISAD IO authorization until the NDS is approved, rejected or withdrawn. This is the case even after the ISAD IO expires.
Many of the regulatory provisions found in the ISAD IO are available when filing a submission under the Regulations. These are further described in:
- Rolling submissions
- Clinical information and requirements
- Non-clinical information and requirements
- Quality (chemistry and manufacturing) information and requirements
- Product labels
- Labelling
An NDS filed under the amended Regulations would support the issuance of the notice of compliance (NOC), along with any applicable terms and conditions. Further details are provided in the:
- Issuance of a notice of compliance for a COVID-19 drug
- Terms and conditions on a drug identification number relying on modified requirements in C.08.002(2.1)
While the NDS is under review, the DIN that was assigned under ISAD IO remains assigned to the drug authorized under ISAD IO. This continues to ensure the operation of all regulatory obligations associated with the drug. Sponsors are invited to discuss with Health Canada their plans for packaging and labelling and reuse of a DIN.
Scenario 2
An NDS is filed for a COVID-19 drug for which an application was never filed under ISAD IO
Manufacturers of new COVID-19 drugs who did not file an application under ISAD IO may file an NDS seeking approval of the drug on the basis of the modified requirements under the amended NDS pathway in the Regulations.
Many of the regulatory provisions found in ISAD IO are available when filing a submission under the Regulations. These are further described in:
- Rolling submissions
- Clinical information and requirements
- Non-clinical information and requirements
- Quality (chemistry and manufacturing) information and requirements
- Product labels
- Labelling
An NDS filed under the amended Regulations would support the issuance of the NOC, along with any applicable terms and conditions. Further details are provided in the:
- Issuance of a notice of compliance for a COVID-19 drug
- Terms and conditions on a drug identification number relying on modified requirements in C.08.002(2.1)
The manufacturer will have to wait to receive an NOC before marketing its drug.
Scenario 3
A submission seeking approval for a subsequent entry drug on the basis of a direct or indirect comparison to a COVID-19 drug (that is, a comparative submission)
Subsequent entry submissions seeking approval for a COVID-19 drug on the basis of a direct or indirect comparison to another COVID-19 drug are not eligible to benefit from the amended Regulations. These submissions will be filed as an ANDS or a comparative NDS.
Scenario 4
Submitting an amendment to an ISAD IO authorization while an NDS has been filed under the Regulations and is under review
Manufacturers can file an amendment to their ISAD IO authorization while an NDS is under review during the period of June 16 to September 16, 2021.
Manufacturers are encouraged to file relevant information under the ISAD IO and under the Food and Drug Regulations. During the June to September transition period, sponsors should discuss their application plan with Health Canada to determine if a concurrent amendment filing under ISAD IO is merited. In this case, both submissions must be filed separately to Health Canada. Health Canada will process amendments to the ISAD IO authorization in parallel to an NDS.
Review decisions for ISAD IO amendments that are not completed by September 16, 2021, will require manufacturers to re-file under the Regulations for further consideration.
Many of the regulatory provisions found in ISAD IO are available when filing a submission under the Regulations. These are further described in:
- Rolling submissions
- Clinical information and requirements
- Non-clinical information and requirements
- Quality (chemistry and manufacturing) information and requirements
- Product labels
- Labelling
An NDS filed under the amended Regulations would support the issuance of the notice of compliance (NOC), along with any applicable terms and conditions. Further details are provided in the:
- Issuance of a notice of compliance for a COVID-19 drug
- Terms and conditions on a drug identification number relying on modified requirements in C.08.002(2.1)
While the NDS is under review, the DIN that was assigned under the ISAD IO remains assigned to the drug authorized under the ISAD IO. This continues to ensure the operation of all regulatory obligations associated with the drug. Sponsors are invited to discuss with Health Canada their plans for packaging and labelling and reuse of a DIN.
Upon issuance of an NOC, the ISAD IO authorization will no longer be valid. Any post-NOC changes would be filed as an SNDS. Please refer to the:
Scenario 5
Submissions for COVID-19 vaccines against variants
Sponsors are encouraged to meet with Health Canada to discuss their development and regulatory filing plans for variant COVID-19 vaccines. This includes sponsors who are:
- modifying authorized COVID-19 vaccines to respond to variants
- developing new vaccine platforms against COVID-19 variants
The submission type for a variant COVID-19 vaccine will depend on the specific vaccine, taking into account:
- the platform used
- whether the proposed variant vaccine is a version of an already authorized COVID-19 vaccine
- the extent of change from the previously authorized version
The emergence of SARS-CoV-2 variants is an evolving field. Please refer to the:
This guidance will be updated as we gain experience with variant COVID-19 vaccines.
Reference documents
Authorization application guidance documents and webpages:
- Management of drug submissions and applications
- Regulatory enrolment process
- Common electronic submissions gateway
- Management of regulatory submissions for veterinary drugs
- Filing submissions electronically
General guidance documents:
- Information and submission requirements for biosimilar biologic drugs
- Drug submissions relying on third-party data (literature and market experience)
- The use of foreign reviews by Health Canada
- Determining prescription status for human and veterinary drugs
- Questions and answers: Prescription drug list
- Regulatory requirements for drug identification numbers (DINs)
- Drug establishment licences and COVID-19
- Good manufacturing practices and COVID-19
- Compliance and enforcement policy for health products (POL-0001)
- Drug and medical device databases
- Regulatory roadmap for biologic (Schedule D) drugs in Canada
Safety and efficacy guidance documents:
- Non-clinical laboratory study data supporting drug product applications and submissions: Adherence to good laboratory practice
- Preparation of comparative bioavailability information for drug submissions in the CTD format
- Cochrane Handbook for Systematic Reviews of Interventions
- Preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement
Quality guidance documents:
- Preparation of quality information for drug submissions in the CTD format: Biotechnological/biological (biotech) products
- Preparation of quality information for drug submissions in the CTD format: Conventional biotherapeutic products
- Quality (chemistry and manufacturing) guidance: New drug submissions (NDSs) and abbreviated new drug submissions (ANDSs)
Labelling guidance documents:
- Review of drug brand names: Guidance document for industry
- Frequently asked questions review of drug brand names
- Good label and package practices guide for prescription drugs (GLPPG)
- Questions and answers: Plain language labelling regulations for prescription drugs
- Labelling of special containers policy
- Labelling of pharmaceutical drugs for human use
- Product monograph guidance documents and notices
COVID-19 vaccines guidance documents:
- Guidance for market authorization requirements for COVID-19 vaccines: Requirements for vaccines to address SARS-CoV-2 variants
- ACCESS Consortium: Points to consider for strain changes in authori zed COVID-19 vaccines in an ongoing SARS-CoV2 pandemic
Establishment licensing guidance documents:
- Guidance on drug establishment licences and drug establishment licensing fees (GUI-0002)
- Management of applications and performance for drug establishment licences (GUI-0127)
Good manufacturing practices (GMP) guidance documents:
- Good manufacturing practices guide for drug products (GUI-0001)
- Annex 2 to the current edition of the good manufacturing practices guidelines schedule D drugs (biological drugs) (GUI-0027)
- How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)
- Good manufacturing practices (GMP) for Active Pharmaceutical Ingredients (APIs) (GUI-0104)
Good laboratory practices (GLP) guidance document:
Post-market vigilance guidance documents:
- Reporting adverse reactions to marketed health products (overview)
- Report an adverse reaction to a drug: industry
- Preparing and submitting summary reports for marketed drugs and natural health products
- Good pharmacovigilance practices (GVP) guidelines (GUI-0102)
- Notifying Health Canada of foreign actions: Guidance document for industry
- Amendments to the Food and Drugs Act: Guide to new authorities (power to require and disclose information, power to order a label change and power to order a recall)
- Format and content for post-market drug benefit-risk assessment in Canada
- Submission of risk management plans and follow-up commitments
- Guide to reporting drug shortages and discontinuations
- Recall policy for health products (POL-0016)
- Drug and natural health products recall guide (GUI-0039)
Post-notice of compliance (NOC) changes guidance documents:
- Framework document (pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
- Quality document
- Safety and efficacy document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
Advertising guidance documents:
Disinfectants guidance documents and monograph:
- Management of disinfectant drug applications
- Safety and efficacy requirements for surface disinfectant drugs
- Disinfectant drugs
- Applying for a drug identification number (DIN) for a disinfectant drug during the COVID-19 pandemic
- Hard-surface disinfectants monograph
Non-prescription pharmaceuticals and hand sanitizer (antiseptic skin cleansers) guidance documents and monographs:
Intellectual property guidance documents:
- Patented Medicines (Notice of Compliance) Regulations
- Data protection under C.08.004.1 of the Food and Drug Regulations
- Certificates of supplementary protection
Key contacts
To help ensure that we prioritize your inquiry, please include "COVID-19 drug" in the subject line of your email.
Biologic and Radiopharmaceutical Drugs Directorate
Office of Regulatory Affairs
Email: brdd.ora@hc-sc.gc.ca
Pharmaceutical Drugs Directorate
Regulatory Project Management Division
Email: rpmd-dgpr@hc-sc.gc.ca
Veterinary Drugs Directorate
Submission and Knowledge Management Division
Email: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca
Natural and Non-prescription Health Products Directorate
General Enquiries
Email: nnhpd-dpsnso@hc-sc.gc.ca
For intellectual property-related inquiries:
Office of Patented Medicines and Liaison
Email: opml-bmbl@hc-sc.gc.ca
For application format-related inquiries:
Office of Submissions and Intellectual Property
Email: ereview@hc-sc.gc.ca
For adverse reaction reporting-related inquiries:
Canada Vigilance Program (CVP)
For inquiries about good manufacturing practices (GMP) compliance requirements:
Email: GMP_Questions_BPF@hc-sc.gc.ca
For drug establishment licensing (DEL)-related inquiries:
Page details
- Date modified: