COVID-19 drug rules added to FDR

Summary#

The Government of Canada registered SOR/2021-45 on March 31, 2021, amending the Food and Drug Regulations to fold some of the emergency rules from the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (ISAD Interim Order) into the regular regulations. Practically, this lets certain COVID‑19 drugs that were handled under the Interim Order continue to be sold or pre‑positioned, and gives manufacturers new, faster ways to file for market approval while keeping safety checks in place.

What it does#

• Adds definitions and new rules so a drug “for use in relation to COVID‑19” can be treated specially under the drug rules.
• Lets manufacturers file a new drug submission (NDS) for a COVID‑19 drug using flexible evidence rules, including:
  • partial or “rolling” submissions when some data are not yet ready; and
  • acceptance of draft labels instead of final mock‑ups in some cases.
• Keeps the ability for the Minister to attach or change terms and conditions to a drug’s authorization (DIN) or an establishment licence to manage ongoing safety or supply risks.
• Lets applicants say on their establishment‑licence application that activities relate to COVID‑19; the Minister must consider the public‑health need for COVID‑19 when deciding.
• Continues the “pre‑positioning” route: a licensed importer can bring a promising COVID‑19 drug into Canada before full Canadian authorization if the Government has a procurement contract and the Chief Public Health Officer notifies the regulator.
• Transitional rule: manufacturers who received authorizations under the Interim Order must file an NDS or supplement within 90 days (or the authorization can be revoked). Existing interim drug identification numbers remain assigned while the transition proceeds.
• Some parts of these changes take effect immediately on registration; other parts come into force when the ISAD Interim Order ends.

Who's affected#

• Manufacturers and sponsors of drugs developed or repurposed for COVID‑19.
• Holders of or applicants for a drug establishment licence (DEL) — importers, fabricators, packagers, labellers and testers.
• Distributors, importers and wholesalers who handle COVID‑19 drugs and provincial/territorial stockpiles.
• Health system planners and patients who rely on timely access to COVID‑19 treatments and vaccines.
• Note: the rules make clear that generic or biosimilar (subsequent‑entry) drugs generally cannot rely on an Interim‑Order authorization as the reference product for approval unless that reference later receives a full notice of compliance.

Why it matters#

• Prevents a sudden gap in access: the changes stop COVID‑19 products that were authorized under the temporary Interim Order from disappearing from the market when that Order ends.
• Speeds access to promising drugs: rolling submissions and some evidence flexibilities can shorten the time it takes for a drug used for COVID‑19 to be reviewed and authorized.
• Balances speed with oversight: the Minister can attach terms and conditions (for example, extra safety monitoring) to manage uncertain risks after faster approvals.
• Small but real government cost: Health Canada estimated the measurable annual administrative cost of these flexibilities at about $363,913, while also forecasting faster patient access as the main benefit.
• In short, these amendments aim to keep supply and access to COVID‑19 drugs steady while moving emergency practices into the regular regulatory framework.