Health Canada Drug Approval Process
How does Health Canada approve drugs?
Health Canada approves a drug by issuing a Drug Identification Number (DIN) and, if the product is a "new drug", a Notice of Compliance (NOC) under Part C of the Food and Drug Regulations (C.R.C., c. 870). It issues them after a scientific review of a submission from the manufacturer. Most innovative and generic medicines are new drugs, so in practice they need both.
Approach: I read the Food and Drug Regulations and the Health Canada drug guidance catalogue, and checked the current review timelines on canada.ca. I could not find section 30.6 of the Food and Drugs Act (the basis for the Reliance Order) in the datasets, so that part relies on Health Canada's draft guidance.
1. The two legal requirements
- DIN: "No manufacturer shall sell a drug in dosage form unless a drug identification number has been assigned" [1]. For a new drug, the new drug submission itself "shall be regarded as an application for a drug identification number" (C.01.014.1(3)) [2].
- NOC: A drug is a "new drug" if its substance, its combination, or its use or conditions of use has not been sold in Canada long enough and in large enough quantity to establish safety and effectiveness (C.08.001) [3]. No one shall sell or advertise a new drug unless the manufacturer has filed a satisfactory submission and the Minister has issued an NOC that has not been suspended (C.08.002(1)) [4].
- Establishment licence: Separately, no person shall fabricate, package/label, import, distribute or wholesale a drug except under an establishment licence (C.01A.004) [5].
2. Before filing: clinical trials in Canada
Under Division 5, a sponsor may sell or import a drug for a trial if it has filed a clinical trial application and the Minister has not objected within 30 days of receiving it. Research ethics board approval is also required for each site (C.05.006) [6].
3. Types of submission
- New Drug Submission (NDS): This is the full dossier. It must contain enough information for the Minister to assess safety and effectiveness. That includes manufacturing methods and controls, safety test reports, "substantial evidence of the clinical effectiveness", and label and package mock-ups (C.08.002(2)) [4]. If the EMA or FDA application broke clinical data down by population subgroup, the Canadian submission must do the same (C.08.002(2.01)) [7].
- Abbreviated NDS (ANDS), for generics: The product must be the pharmaceutical equivalent of, and bioequivalent to, a Canadian reference product, with the same route and conditions of use that fall within the reference product's (C.08.002.1) [8]. The resulting NOC "shall constitute a declaration of equivalence" (C.08.004(4)) [9].
- Other types: The submission management guidance also covers supplements (SNDS/SANDS), extraordinary use submissions (EUNDS), confirmatory supplements, and DIN-only applications for products that are not new drugs [10].
- Public health emergency drugs: A submission may be filed without the usual safety and efficacy evidence if it shows the benefits outweigh the risks for a condition on the List of Conditions that Threaten Public Health (C.08.002(2.1)-(2.4)) [7].
4. Review process
- Screening, then review: Each submission is screened first. Acceptance starts the scientific review, in which "the reviewer examines and analyzes the information submitted to ensure the product meets the requirements" of the Regulations (Health Canada, review).
- Decision: After examining the submission, the Minister "shall" issue an NOC if it complies, or a notice to the manufacturer if it does not. The manufacturer may respond with more information within 90 days, or a longer period set by the Minister (C.08.004(1)-(3)) [9]. Health Canada's guidance calls these notices a Notice of Deficiency or a Notice of Non-compliance.
- Tracking and reconsideration: Sponsors can follow their submission's status online through the Drug Submission Tracking System. They can also ask for a negative decision to be reconsidered [10].
Target timelines (calendar days, from Health Canada's performance standards table):
| Pathway | Screening | First review | Screening of response | Review of response |
|---|---|---|---|---|
| NDS, new active substance | 45 | 300 | 45 | 150 |
| ANDS (comparative data) | 45 | 180 | 45 | 150 |
| Priority NDS | 25 | 180 | 25 | 90 |
| NOC/c NDS | 25 | 200 | 25 | 90 |
Source: Health Canada, performance standards. The clock excludes review pauses.
5. Faster pathways
- Priority Review: For a serious, life-threatening or severely debilitating condition, with substantial evidence that the drug either treats a condition no marketed drug addresses or clearly improves benefit/risk over existing therapy.
- Health Canada decides on the request within 30 days. The sponsor must then file within 60 days, and the review target is 180 days.
- "Substantial evidence" generally means at least two adequate, well-controlled studies.
- This guidance dates from 2009 and still names the former directorates [11].
- NOC with Conditions (NOC/c): For the same kinds of serious conditions, based on promising evidence of clinical effectiveness. The sponsor signs a Letter of Undertaking to run confirmatory trials. The conditions are lifted once those results are reviewed favourably (guidance effective June 30, 2011: Health Canada, NOC/c). New draft guidance on promising-evidence submissions and terms and conditions is out for consultation [12].
- Ministerial Reliance Order: The Minister can treat parts of the review as already done, based on decisions by listed foreign regulators. This applies to NDS, ANDS and their supplements for listed drug classes.
- The Canadian drug must have the same strength, dosage form, route and medicinal ingredients as the foreign one.
- The full Canadian dossier is still required, and Health Canada always examines Canada-specific items such as labelling and risk management plans.
- The guidance is in draft, published 2026-07-15 [13].
6. Data protection for innovative drugs
A generic or other comparative submission referencing an innovative drug cannot be filed before 6 years, or approved before 8 years, from the innovator's first NOC. The 8 years becomes 8 years and 6 months if qualifying paediatric trials are provided. This protection does not apply if the innovative drug is not marketed in Canada (C.08.004.1) [14].
7. After approval
- Changes: Significant changes to the product, its manufacture, labels or claims need a supplement and a new NOC before sale (C.08.003) [15].
- Suspension: The Minister may suspend an NOC for reasons including new safety evidence, a lack of substantial evidence of effect, false statements, or inadequate manufacturing controls (C.08.006) [16].
- Assessment orders: The Minister may order a holder to assess the drug if its benefits or risks are significantly different than when it was authorised (C.01.052) [17].
How can I check whether a drug is approved?
In Canada, look the product up in Health Canada's Drug Product Database (DPD) by DIN, brand name or company. A product that has a DIN and a current status in the DPD is authorised for sale. For new drugs, you can confirm the underlying Notice of Compliance (NOC) in the NOC database and read the reasoning in the Regulatory Decision Summary (RDS). I used semaglutide (Wegovy) as a worked example.
Approach: I searched Health Canada's Drug Product Database (both the product listing and the full data extracts), the Notice of Compliance database and the Regulatory Decision Summaries.
1. Drug Product Database: is there a DIN, and what is its status?
- Search by DIN, brand or company. Each DPD entry gives you the DIN, brand name, class (e.g. Human), DIN owner and last update date. For example, WEGOVY single-dose prefilled pen has DIN 02522551 and is held by Novo Nordisk Canada Inc [18].
- Check the status record. This DIN's status reads
STATUS=APPROVED, withCURRENT_STATUS_FLAG=Yand a history date of 23-NOV-2021 [19]. Health Canada publishes the DPD extracts in four groups: marketed, approved, dormant and cancelled. Look at the status, because a cancelled DIN stays in the database. - Confirm the product matches yours. The DPD holds linked records for:
- A DIN covers one specific product, so each strength or presentation has its own. Wegovy alone has several pen DINs (02522551, 02522578, 02522586, 02522594, 02522608) [26][27][28][29].
2. Notice of Compliance database: was a new drug approved through an NDS or ANDS?
Each NOC record gives the NOC number, date, manufacturer, submission type and medicinal ingredient. For example, NOC 23396 is dated 20-03-30 and was issued to Novo Nordisk Canada Inc for a New Drug Submission (NDS) for semaglutide, classed as a Biologic [30]. Searching by ingredient also turns up later Novo Nordisk NOCs for semaglutide, such as 36539 (25-12-10) and 36609/36610 (25-12-22) [31][32].
3. Regulatory Decision Summaries: the decision and why
Each RDS states the decision, its date and the application number:
| Product | Holder | Decision | Date |
|---|---|---|---|
| Wegovy | Novo Nordisk Canada Inc. | Approved, NOC issued | 2021-11-23 [33] |
| Ozempic | Novo Nordisk Canada Inc. | Authorized, NOC issued | 2023-08-04 [34] |
| Rybelsus | Novo Nordisk Canada Inc. | Authorized, NOC issued | 2024-10-08 [35] |
| Semaglutide Injection | Dr Reddys Laboratories Ltd | Authorized, NOC issued | 2026-04-28 [36] |
| Apo-Semaglutide Injection | Apotex Inc. | Authorized, NOC issued | 2026-05-01 [37] |
How to use them together
- Is it legal to sell? Find the exact DIN in the DPD and check that its current status is not cancelled.
- On what basis was it authorised? Find the NOC by ingredient or company and note the submission type (NDS, ANDS or a supplement).
- What did Health Canada conclude? Read the RDS.
Natural health products (NPN) and medical devices have their own registers and are not in the DPD.
If you give me a specific product, DIN or ingredient, I can run all three checks for it.
Does FDA approval apply in Canada?
No. An FDA approval does not authorise sale in Canada. A drug needs its own Health Canada authorisation: a DIN and, for a new drug, a Notice of Compliance. The FDA decision counts only in specific, limited ways: as evidence Health Canada may take into account or rely on, and under a few emergency and shortage rules.
Approach: I searched the Food and Drugs Act, the Food and Drug Regulations (C.R.C., c. 870) and Health Canada's drug guidance catalogue. In my last answer I said I couldn't find the Act's reliance provision. It is in the consolidated Act text, and I cite it below.
The baseline: Canadian authorisation is still required
- The regulations do not exempt FDA-approved products from the DIN and NOC requirements (C.01.014, C.08.002) covered in my first answer.
- Health Canada's FAQ on its use of foreign reviews says "All final regulatory decisions to grant or refuse market authorization must be made by the Minister of Health". It also says the initiative "will not harmonize Canadian health product legislation or regulations with those of any foreign regulatory counterpart" [38].
Where an FDA decision does count
1. As evidence in a Canadian review. When examining an NDS, ANDS or supplement, the Minister "may" examine information "obtained directly or indirectly from a foreign regulatory authority" (C.08.003.1(c)) [39]. Health Canada will consider a foreign review from any foreign authority. It will not hold up its own decision waiting for one, and it may ask the foreign regulator for the review directly [38].
2. Reliance (deeming).
- The legal basis. The Act lets the Minister, by order, "deem that specified requirements of this Act or the regulations are met" for a class of therapeutic products, based on a foreign regulatory authority's decision or documents. The order must be needed for a health or safety purpose, or otherwise be in the public interest, and must be unlikely to create unacceptable risk or uncertainty (s. 30.06) [40].
- What the guidance requires. Health Canada's draft guidance on the Ministerial Reliance Order was published 2026-07-15 [13]. Under it, a manufacturer must:
- ask for deeming when filing,
- still file a complete Canadian submission (NDS, ANDS, SNDS or SANDS), and
- show that the drug is in a class listed on the incorporated-by-reference list against a listed foreign regulatory authority.
- Product match. The Canadian drug must have the same strength, dosage form, route and medicinal ingredient as the foreign drug, with conditions of use that fall within the foreign authorisation.
- When deeming is ruled out. The foreign approval must not itself rest on another regulator's decision, unless that was a joint review. Deeming is also unavailable if an earlier Canadian submission for the drug was withdrawn or cancelled after a deficiency, non-compliance or refusal.
- What Health Canada always reviews itself. Labelling, bilingual requirements, risk management plans, and any differences from the foreign drug.
- Out of scope. Extraordinary use submissions and public health emergency drugs.
- The FDA's place. The guidance does not name the FDA. Whether it is a listed authority for a given drug class depends on that list, which I did not retrieve.
3. Emergency access for one patient (C.08.010). The Minister "may" issue a letter of authorisation for a practitioner to obtain an unapproved new drug for emergency treatment. Normally the practitioner must supply the safety and efficacy information they hold. That requirement drops away if all three of these apply:
- the sale has been authorised for the same emergency at least once before;
- "the European Medicines Agency or the United States Food and Drug Administration has authorized the sale of the new drug without terms or conditions, for the same use"; and
- the drug's DIN has not been cancelled under the listed provisions (C.08.010(2)) [41].
4. Urgent public health need (C.10.001). A licensed importer "may" import a drug that has no NOC or DIN if all of these apply:
- a public health official has notified the Minister of an urgent need within the past year;
- the drug is authorised in the United States, the United Kingdom, Switzerland or the European Union for the same use;
- it is imported directly from that country; and
- it appears on the List of Drugs for an Urgent Public Health Need [42].
Such a drug may be sold only within that official's jurisdiction, for the same need (C.10.002) [43].
5. Exceptional importation for shortages (C.10.005). The Minister "may" add a foreign-made drug to the List of Drugs for Exceptional Importation and Sale only if, among other conditions, it "is authorized to be sold by a foreign regulatory authority within its jurisdiction" [44].
6. After approval: foreign safety actions. Holders of drugs in certain classes "shall" tell the Minister about serious risks, labelling changes, and recalls or suspensions communicated by or carried out by the foreign regulatory authorities on Health Canada's published list (C.01.050) [45].