Reliance Order to Speed Drug Approvals

Summary#

The federal government (through Health Canada) has made the Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs. It lets Health Canada treat some parts of a Canadian drug application as already examined when a trusted foreign regulator has approved or reviewed a closely matching product. The Order takes effect on July 15, 2026.

What it does#

• Creates a way for the Minister of Health to “deem” that parts of the required review for a new drug, an abbreviated new drug, or a supplement are already done because:
  • a listed foreign regulator has already authorized a matching foreign drug (General Deeming);
  • a company files in Canada within 120 days of filing with a listed foreign regulator so Canada can rely on an expected foreign decision (the 120‑day Filing option); or
  • Health Canada and a listed foreign regulator did a joint review and produced documents that can be relied on (Joint Reviews).
• Limits what can be deemed to specific parts of an application: chemistry and manufacturing information, non‑clinical studies, and clinical evidence. Health Canada will still review Canadian‑specific items such as labelling and risk‑management plans.
• Requires the manufacturer to show the proposed Canadian drug has the same medicinal ingredient(s), strength, dosage form and route of administration as the foreign product, and that any differences would not affect safety or effectiveness.
• Requires manufacturers to provide recent foreign labels, describe relevant post‑market measures, and give foreign refusal/withdrawal decisions if they have them.
• Uses a public list (the “IbR List”) that names which drug classes and which foreign regulators can be relied on. Health Canada will maintain and update that list and publish guidance.
• Keeps Health Canada’s final authority to approve or refuse a drug. Deeming only affects parts of the technical examination; it does not automatically grant a Canadian marketing authorization.

Who's affected#

• Drug manufacturers and sponsors that file new drug submissions, abbreviated submissions, or supplements. These companies are the primary users of the new deeming options.
• Patients and health care providers, because the Order is meant to speed access to some drugs that are already approved abroad.
• Health system partners such as health technology assessment bodies and provincial/territorial drug plans, who may see changes in the timing and number of newly authorized drugs.
• Domestic manufacturers could face more competition from internationally approved products. Small Canadian firms are less likely to use the Order because they typically won’t hold foreign authorizations to rely on.
• Health Canada will have new verification and operational tasks (tracking the IbR List, checking eligibility, and possibly asking for more information).

Why it matters#

• It aims to speed up access to certain medicines in Canada by using trusted foreign reviews instead of repeating every technical analysis from scratch. Health Canada estimates some submissions could be up to 40% faster when reliance is used for all three information sets.
• There is an estimated average net savings to industry of $18,075 per submission where deeming applies ($27,675 average savings from fewer information requests minus $9,600 average cost to demonstrate eligibility and differences). The number of submissions that will use this route is uncertain.
• Health Canada says it will still examine Canadian‑specific issues and can refuse a drug if differences raise safety or effectiveness concerns. The Order does not change intellectual property protections or the Minister’s final decision power.
• Potential trade‑offs: faster access for patients, but possible increased competition for domestic manufacturers and uncertainty about how many drugs will actually be brought to Canada under this option.
• Some additional rules come into play soon: risk‑management package requirements and the power to add or change terms and conditions for authorizations take fuller effect on April 1, 2027. Health Canada will publish guidance and update the IbR List publicly as the program is used.