As previously reported here, on September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order), which introduced a new pathway to expedite the authorization for importing, selling and advertising of COVID-19 drugs. As of April 15, 2021, Health Canada had granted seven (including five vaccine) authorizations under the ISAD Interim Order. As the ISAD Interim Order expires on September 16, 2021, the Food and Drug Regulations (FDR) were amended on March 18, 2021 - Regulations Amending the Food and Drug Regulations (Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19) - to allow, among other things, continued sale of COVID-19 drugs authorized under the ISAD Interim Order. See accompanying Notice and Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19.
Generally, amendments to the FDR related to the authorization pathways and associated submission flexibilities, including the modified safety and efficacy information requirements, rolling submissions, and terms and conditions, came into force on March 18, 2021. Most amendments relating to drug establishment licencing (DEL), good manufacturing practices (GMP), pre-positioning and other provisions relating to authorization pathways will come into force upon expiry of the ISAD Interim Order, on September 16, 2021.
As explained in the Regulatory Impact Analysis Statement:
“These amendments to the FDR will allow for continued and timely access to safe and effective COVID-19 drugs for Canadians by normalizing the review, authorization and oversight of these drugs under the FDR by
- enabling the sale and advertising of COVID-19 drugs that were authorized under the ISAD Interim Order, not including those generic drugs authorized to alleviate shortages, to continue without interruption after the Interim Order ceases to have effect, and once authorized under the FDR;
- enabling both COVID-19 drugs that have been authorized under the ISAD Interim Order and new COVID-19 drugs that have not been authorized under the ISAD Interim Order to seek authorization under the FDR with similar flexibilities as had been provided under the Interim Order, such as rolling submissions and the ability to impose and amend terms and conditions;
- permitting continuity of the post-market regulatory obligations placed on authorization holders, manufacturers and importers after expiration of the ISAD Interim Order;
- continuing to provide a legal pathway that allows the early importation (pre-positioning) of a promising COVID-19 drug, for which a Government of Canada contract for its procurement is in place, prior to that drug receiving market authorization in Canada; and
- enabling the continuity of a flexible approach for DELs that authorizes regulated activities in respect of COVID-19 drugs.”
Intellectual property consequences –Sponsors may now benefit from intellectual property protections available in connection with submissions resulting in a notice of compliance (NOC), namely data protection, protection under the Patented Medicines (Notice of Compliance) Regulations, and protection under the Certificate of Supplementary Protection regime.
Deadlines - To maintain the ability to sell, import or conduct other licensable activities related to a COVID-19 drug, manufacturers holding an authorization are required to submit a New Drug Submission (NDS) or Supplement to a New Drug Submission (SNDS) within
- ninety days following the coming into force of the amendments (i.e. June 16, 2021) if the holder receives authorization prior to March 18, 2021; or
- ninety days following issuance of an authorization under the ISAD Interim Order if the holder receives their authorization on or after March 18, 2021.
An authorization under the ISAD Interim Order will be revoked if
- an NOC is issued under the FDR for a drug authorized under the ISAD Interim Order while the ISAD Interim Order is in effect; or
- an NDS or SNDS submitted under the FDR for a drug that is authorized under the ISAD Interim Order does not meet the submission requirements and the authorization holder either does not provide additional information requested in the period specified by the Minister or the information that is provided is not sufficient and the Minister issues a notice to that effect under paragraph C.08.004(3)(b).
A manufacturer will be permitted to continue selling, within the scope of their authorization, the COVID-19 drug once the ISAD Interim Order ceases to have effect if
- they had received an authorization under the ISAD Interim Order;
- their authorization had not been revoked or suspended in whole when the ISAD Interim Order ceased to have effect; and
- they met the timelines for submission of an NDS or SNDS.
If the holder of an Interim Order authorization is not able to file an NDS or an SNDS, as applicable, within the given timeline, the Interim Order authorization is revoked, and the manufacturer will have to wait until receiving an NOC to continue sale.