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

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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:

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can continue selling the COVID-19 drug under the ISAD IO authorization until the NDS is approved, rejected or withdrawn.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:

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:

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:

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:

The manufacturer will have to wait to receive an NOC before marketing its drug.

Scenario 3

An SNDS for a marketed drug is filed where an expanded indication for COVID-19 was authorized under ISAD IO

Where an expanded indication for COVID-19 was authorized under ISAD IO for a marketed drug, the manufacturer is able to submit an SNDS to add the new COVID-19 indication. The amended Regulations, including the ability to file an incomplete submission (rolling submission), are not available in this scenario.

To maintain the ability to sell the drug for use in relation to COVID-19, the SNDS must be filed:

Manufacturers can continue selling the COVID-19 drug under ISAD IO authorization until the SNDS is approved, rejected or withdrawn (even after the ISAD IO expires). Manufacturers are encouraged to file the SNDS before ISAD IO authorization ceases to have effect.

The manufacturer must include all available known information on the use of the approved drug for COVID-19.

Scenario 4

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 5

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:

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:

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 6

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:

The submission type for a variant COVID-19 vaccine will depend on the specific vaccine, taking into account:

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:

General guidance documents:

Safety and efficacy guidance documents:

Quality guidance documents:

Labelling guidance documents:

COVID-19 vaccines guidance documents:

Establishment licensing guidance documents:

Good manufacturing practices (GMP) guidance documents:

Good laboratory practices (GLP) guidance document:

Post-market vigilance guidance documents:

Post-notice of compliance (NOC) changes guidance documents:

Advertising guidance documents:

Disinfectants guidance documents and monograph:

Non-prescription pharmaceuticals and hand sanitizer (antiseptic skin cleansers) guidance documents and monographs:

Intellectual property guidance documents:

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: hc.brdd.ora.sc@canada.ca

Therapeutic Products Directorate
Regulatory Project Management Division
Email: hc.rpmd-dgpr.sc@canada.ca

Veterinary Drugs Directorate
Submission and Knowledge Management Division
Email: hc.vdd.skmd.so-dgps.dmv.cp.sc@canada.ca

Natural and Non-prescription Health Products Directorate
General Enquiries
Email: hc.nnhpd-dpsnso.sc@canada.ca

For intellectual property-related inquiries:

Office of Patented Medicines and Liaison
Email: hc.opml-bmbl.sc@canada.ca

For application format-related inquiries:

Office of Submissions and Intellectual Property
Email: hc.ereview.sc@canada.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:

Email: hc.del.questions-leppp.sc@canada.ca

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