Who approves prescription drugs in Canada?

Health Canada. Its review decides whether a drug can be sold in Canada. Public funding is a separate decision made by provincial, territorial and federal drug plans after a funding assessment and price negotiations.

Does Health Canada approval mean my province will pay for the drug?

No. Approval only means the drug can be sold in Canada. Public funding requires a funding assessment, price negotiations, and a listing decision by each province — steps that take about two years on average after approval.

How long does it take for a new drug to be approved and funded in Canada?

Health Canada's review targets 300 days, or 180 days for priority review. After approval, public funding takes about two years on average for recent cancer drugs, though steps can overlap and timelines vary.

Who decides what a new drug costs in Canada?

The manufacturer sets an initial price, capped by the federal Patented Medicine Prices Review Board. The price public drug plans actually pay is negotiated confidentially by the pan-Canadian Pharmaceutical Alliance (pCPA).

Why does Quebec have its own drug assessment process?

Quebec runs its funding assessments through INESSS instead of Canada's Drug Agency, so its recommendation and timeline are separate. Quebec still takes part in pCPA price negotiations.

Can I get a drug in Canada before it is publicly funded?

Sometimes. Options include clinical trials, the Special Access Programme for unauthorized drugs (a doctor applies and the manufacturer must agree to supply it), private insurance after Health Canada approval, and manufacturer patient-support programs.

Xianjie Li Updated on Oct 21, 2026

How Does a New Drug Get Approved and Funded in Canada?

The four steps a new drug goes through in Canada — Health Canada review, funding assessment, price negotiations, and coverage decisions — and why approval doesn't mean coverage.