New pathway to expedite authorization for importing, selling and advertising COVID-19 drugs

Drug Establishment Licensing Bulletin 95, September 17, 2020

On this page

• Interim Order creates new pathway
• Licensing and authorization requirements
• Fees
• Submitting an application for authorization and licensing
• Coming into force and expiry
• Contact us

Interim Order creates new pathway

The Minister of Health approved an Interim Order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 on September 16, 2020.

This interim order (IO) responds to the urgent need for COVID-19 diagnosis, treatment, mitigation or prevention options. The IO introduces a new pathway with regulatory mechanisms to expedite the authorization for importing, selling and advertising COVID-19 drugs during a public health emergency without compromising patient safety.

Health Canada has published a notice and a guidance document to accompany the IO. We have also created frequently asked questions related to the IO. For a copy of this document, contact us at hc.hpfb-covid19-dgpsa.sc@canada.ca.

We encourage you to share this announcement and website links within your networks.

Licensing and authorization requirements

COVID-19 drugs may be authorized under this IO or under Division 8 of the Food and Drug Regulations (FDR).

The IO pathway introduces 3 mechanisms for Health Canada to expedite the availability of COVID-19 drugs in Canada by:

1. authorizing a new drug with a modified set of application requirements (with the potential for a "rolling" submission of information as it becomes available)
2. authorizing a drug based on certain elements being approved by a foreign regulatory authority
3. expanding the indication for a drug already approved

The IO introduces an option for drug establishment licences (DELs) to be issued or amended to include the conduct of activities in relation to COVID-19 drugs. This balances the need for flexibilities, such as modifying certain good manufacturing practices (GMP) requirements, while protecting the health and safety of people who will use these drugs.

All DEL applications submitted under the IO will be processed as quickly as possible. When deciding to license a drug, Health Canada will consider the information in the application and the need for the drug to address urgent COVID-19-related health needs.

Fees

Fees for regulatory activities related to human and veterinary drugs are normally charged as per the Fees in respect of drugs and medical devices order. However, these fees do not apply to applications for authorizing a COVID-19 drug submitted under the IO. Thus, there are no cost-recovery fees to review an application and no fees for authorization holders to sell COVID-19 drugs.

The Establishment Licence Fees Remission Order - Indication of an Activity in respect of a COVID-19 Drug (Remission Order) allows for fees associated with DEL applications submitted under the IO to be remitted. Fees will also be remitted for reviewing applications:

• for a new DEL
• to amend an existing DEL
• for the annual licence review of DELs submitted under the IO

For more information, applicants may refer to the section "DEL fee remission" of the new guidance document:

• Information and application requirements for drugs authorized under the Interim Order

Submitting an application for authorization and licensing

Details about how to submit an application for authorization under the IO are outlined in this new guidance document. Please contact us if you have questions on what is needed to meet the regulatory requirements or to submit an application.

We will be engaging with stakeholders and accepting comments on the guidance document. Please provide feedback by email to hc.hpfb-covid19-dgpsa.sc@canada.ca by October 8, 2020.

Coming into force and expiry

Once it's approved by the Governor-in-Council, the IO is valid for a 1-year term from the day it is signed by the Minister. Product authorizations and DELs issued under this IO are only valid while the IO is in effect.

Health Canada is developing transition measures to avoid disruptions for the ongoing authorization of drugs. The measures will be developed in collaboration with Innovation, Science and Economic Development Canada and in consultation with industry and other stakeholders. They will be in place before the IO expires.

The review of COVID-19 drug applications is a priority. We want to ensure the timely access to novel drugs without compromising the safety, efficacy and quality of products.

We look forward to working together with the intent of finding safe and effective treatment options for patients affected by COVID-19.

Contact us

For people living in Canada, health care providers and health care system partners have the latest information on COVID-19 drugs, Health Canada maintains the following lists:

• List of applications received for drugs for use in COVID-19
• List of drugs authorized for use in COVID-19
• List of new drugs for expanded indication in relation to the COVID-19 pandemic
• List of foreign drugs in relation to the COVID-19 pandemic

For information on drug authorizations under this IO, please contact: hc.hpfb-covid19-dgpsa.sc@canada.ca.

For inquiries related to GMP compliance requirements, please contact: GMP_Questions_BPF@hc-sc.gc.ca.

For DEL inquiries, please contact: hc.del.questions-leppp.sc@canada.ca.

Please include "COVID-19 drug" in the subject of your email to ensure a prompt reply.