Importing Medicines into the United States and Canada: A Country-by-Country Guide (2026)

Last updated: 8 October 2026. Part of our region-by-region import guide series. Covers the United States and Canada.

In North America, the question isn't who may import. It's whether your product and your plant are approved. The US FDA approves every prescription medicine itself, through an NDA, an ANDA, a 505(b)(2) application or a biologics licence, and it doesn't take approvals from other regulators on trust. Every foreign plant must register with the FDA and name a US agent, and each shipment is screened at the border. Canada asks for a Health Canada authorisation (a DIN, plus a Notice of Compliance for new drugs) and an importer with a Drug Establishment Licence that lists your plant. Canada now also relies on some foreign decisions, though not yet for generics. In 2026, US tariffs of up to 100% apply to patented medicines, while generics and biosimilars are exempt for now.

This guide walks through both markets in plain language:

• The United States: approval routes, site registration and the US agent, drug master files, inspections, border clearance, track-and-trace, over-the-counter monographs, patient access routes, state importation from Canada and the 2026 tariffs.
• Canada: DINs and Notices of Compliance, the importer's licence, GMP evidence for foreign plants, the new reliance order, the Special Access Program, shortage imports and pricing.

It's written for manufacturers exporting to North America in India, China, Korea, Japan, Europe, the UK and elsewhere, and for the US and Canadian importers, distributors and licence partners who work with them.

How the region works

The same three doors exist here as everywhere else: get approved and sell commercially, sell to public buyers, or use a special route for a medicine a patient needs. But the weight is different. In the US and Canada, almost everything depends on the first door.

• Full approval is the main route. The FDA reviews every new drug, generic and biosimilar. Health Canada does the same through new drug submissions (NDS) and abbreviated new drug submissions (ANDS).
• One dossier format. Both regulators use the ICH Common Technical Document. The FDA requires the electronic version (eCTD) for NDAs, ANDAs, biologics licence applications and drug master files. Our guide to CTD vs ACTD explains the formats.
• Reliance is new and narrow. The FDA doesn't approve products because another regulator did. Canada began relying on foreign decisions in July 2026, but only for a short list of mostly paediatric and unmet-need medicines.
• The plant matters as much as the product. The FDA inspects foreign plants before and after approval. Canada wants GMP evidence for every foreign site listed on its importer's licence.
• Patient access routes exist for medicines that aren't approved: expanded access in the US, and the Special Access Program in Canada.
• Trade policy is now part of the picture. US Section 232 tariffs on patented medicines took full effect on 29 September 2026. Canada, for its part, bans exports of medicines meant for Canadians when that could cause a shortage.

The two markets at a glance

The United States

Getting approved

• New drugs (NDA): a full application with your own safety and efficacy data. PDUFA VII goals run to the end of September 2027: 90% of standard new molecular entities reviewed within 10 months of the 60-day filing date, and priority ones within 6. The FY2027 fee is $4,600,753 for an application with clinical data.
• Generics (ANDA): no animal or clinical trials, but you must show bioequivalence to the brand. Under GDUFA III, the FDA aims to act on 90% of standard ANDAs within 10 months of submission. Priority ANDAs get 8 months if you file a complete pre-submission facility correspondence at least 60 days ahead. The FY2027 ANDA fee is $375,684.
• 505(b)(2): an NDA that relies partly on studies you didn't run, such as published literature or the FDA's findings for an approved drug. It's the route for a new dosage form, strength, route of administration or indication. If your product duplicates an approved drug, the FDA generally won't accept a 505(b)(2) and expects an ANDA.
• Biosimilars (351(k) BLA): in October 2025, the FDA said it generally no longer expects comparative efficacy trials or switching studies. In March 2026, it went further: in some cases you can rely on clinical data from a comparator approved outside the US, without a three-way PK study. The FY2027 biosimilar fee is $1,124,936 for an application with clinical data.
• Annual programme fees come on top. Every plant named in a generic application pays a GDUFA facility fee each year. For FY2027, that's $245,033 for a foreign finished-dose plant and $54,680 for a foreign API plant, $15,000 more than a US one in each case.

Registering your plants and APIs

• Establishment registration: every plant that makes, repacks or relabels drugs for the US registers with the FDA before its products are offered for import. You renew each year between 1 October and 31 December, and update drug listings in June and December.
• The US agent: foreign plants must give the name and DUNS number of a US agent, and of every known US importer. Each plant needs its own DUNS number, not the head office's.
• Drug master files (DMFs): the FDA doesn't approve APIs separately. API makers file a Type II DMF and give each customer a letter authorising reference to it. For DMFs supporting generics, you pay a one-time GDUFA fee ($109,899 for FY2027). The FDA then runs a completeness assessment and lists the DMF as available for reference. See our explainers on what a DMF is and CEP vs DMF vs ASMF.

GMP and inspections

• Before approval: the FDA may inspect any plant named in an application, and goal dates can move if a facility isn't ready.
• After approval: surveillance inspections continue. In May 2025, the FDA announced it would use more unannounced inspections at foreign plants. It said it had found serious problems at foreign sites more than twice as often as at US ones.
• Refusing, delaying or limiting an inspection can trigger regulatory action, the FDA says. That matters because a plant that loses FDA's confidence can end up on an import alert.

Getting goods through the border

• What the FDA checks: registration, listing, the drug application, labelling and cGMP. A product that needs an NDA, ANDA, BLA or IND and doesn't have one will be refused.
• Entry data: the customs entry carries FDA codes for the registration, listing and application numbers. Correct codes help a shipment clear without manual review. The FDA screens every entry electronically and gives it a risk score, and its reviewers use tools such as PREDICT to decide what to examine or sample.
• Possible outcomes: release, a request for documents, an examination or sample, detention, or refusal. Release doesn't stop the FDA acting later if a problem turns up.
• Import alerts: firms on an alert's "red list" face detention without physical examination. Each future shipment is held and refused unless the importer proves it's compliant. Each alert explains what evidence can support removal.
• Track-and-trace (DSCSA): the law's enhanced, package-level tracing rules began in November 2023, with transaction data exchanged electronically. FDA exemptions ended in 2025 for manufacturers, repackagers, wholesalers and most dispensers. In August 2026, the FDA extended the exemption for dispensers with 25 or fewer pharmacy staff until 27 November 2027. As an exporter, serialise and share data to the US standard from day one.

Over-the-counter medicines

• Monograph route: since the CARES Act of March 2020, an OTC drug can be sold without an approved application if it meets the conditions in an FDA monograph. Those conditions cover the active ingredient, indication, dose and labelling. The FDA now adds or changes monograph conditions by administrative order.
• Fees still apply: the OTC monograph user-fee programme was renewed as OMUFA II. For FY2027, each monograph drug plant pays $47,891 and each contract manufacturer $31,927. OTC plants must also register and list like any other.

Selling without full approval

• Expanded access: a patient with a serious or life-threatening condition can get an investigational medicine outside a trial. There must be no comparable alternative, the patient must be unable to join a trial, and supply mustn't hold up development. Our guide to early access and managed access programmes covers the paperwork.
• Personal importation: this is enforcement discretion, not a right. For serious conditions, FDA staff may allow up to about three months' supply for personal use. There must be no effective US treatment, and the product mustn't be promoted to US residents. Shipments that look commercial are refused, so this is never a route for trade.

Tariffs in 2025 and 2026

• How it started: the Commerce Department opened a Section 232 national-security investigation into pharmaceutical imports on 1 April 2025.
• The proclamation: Proclamation 11020, signed on 2 April 2026, put a 100% duty on patented medicines and their ingredients, meaning products with a patent listed in the Orange or Purple Book. It applied from 31 July 2026 for a named group of large companies, and from 29 September 2026 for everyone else.
• Lower rates: products of the EU, Japan, Korea, Switzerland and Liechtenstein pay 15%. UK products pay 0% from 31 July 2026 under the US–UK pricing arrangement. Companies with approved US onshoring plans pay 20% until April 2030. Companies that also have pricing agreements with the government pay 0% until 20 January 2029. Orphan drugs and some specialty products, such as cell and gene therapies, can qualify for 0%.
• Generics and biosimilars are exempt for now. Commerce must report within a year on whether to extend the tariff to them. In July 2026, the President announced plans for tariffs on generics from August 2028. As of early October 2026, no proclamation had been published.
• Other duties: the Section 301 "forced labour" tariffs that started on 24 July 2026 exclude pharmaceuticals and APIs. The pharma proclamation sets no special rate for Canada or Mexico, so check your goods' treatment with a customs broker.

Canada

Getting authorised

• Every medicine needs a DIN. Human drugs must carry an eight-digit Drug Identification Number before they're sold. New drugs and generics also need a Notice of Compliance (NOC), issued after an NDS or ANDS review.
• Generics (ANDS): filed on comparative studies, such as bioequivalence, against the Canadian reference product. Health Canada's target is 45 days' screening and then a 180-day review. The 2026–27 fee is C$71,953.
• New drugs (NDS): the target is a 300-day review for a new active substance, or 180 days on priority review. The 2026–27 fee for a new active substance is C$616,593.
• Biosimilars and Schedule C/D products: biologics (Schedule D) and radiopharmaceuticals (Schedule C) carry extra controls. Biosimilars are filed as an NDS. Health Canada's guidance of May 2026 says comparative efficacy trials aren't usually needed when analytical studies are strong.
• Simpler products: a DIN application that attests to a labelling standard or a Category IV monograph costs C$1,945 and has a much shorter target. It's a common route for non-prescription products that follow a standard.
• Master files: Canada runs its own master file system. Confusingly, an API master file is Type I in Canada, not Type II as in the US. The holder sends Health Canada a letter of access for each applicant. Your FDA DMF won't carry over, so plan a separate filing.

Reliance

• The Ministerial Reliance Order: in force since 15 July 2026, it lets Health Canada treat parts of a review as done, based on the work of trusted foreign regulators. These are generally the EU, Swiss, UK and US regulators, and in some cases Australia's. Joint reviews are open with Australia, Singapore, Switzerland and the UK.
• Scope is narrow for now. The first list covers mostly paediatric medicines and a few for tuberculosis, rare diseases and other unmet needs. Generics and biosimilars aren't included yet. They're expected in a later phase, and Health Canada's draft guidance consultation closed on 12 September 2026.

Importing

• Who imports: a Canadian business holding a Drug Establishment Licence (DEL) for importation. The importer takes on all regulatory responsibility for the product in Canada. The 2026–27 DEL fee for the importation activity is C$38,916.
• Your plant goes on the importer's licence. Each foreign site that makes, packages or tests the product must be listed on the importer's DEL, and it must be shown to be GMP-compliant.
• At the border: the Canada Border Services Agency can hold products and refer them to Health Canada. Shipments should carry the DIN on the label, papers showing licensed parties, and the DEL details.
• Personal imports: anything over a 90-day supply, without a good reason, may be treated as commercial.

GMP evidence for foreign plants

• MRA countries: Canada has GMP mutual recognition agreements with the EU, Switzerland, Iceland, Liechtenstein, Norway, Australia and the UK. A valid certificate of compliance from those regulators counts as evidence, though APIs are temporarily excluded from some MRAs. There is no MRA with the US.
• Everyone else: Health Canada accepts the latest inspection report from a regulatory authority, usually from the last three years. API sites can also use WHO or EDQM reports. Consultant audits are accepted only in limited cases, such as OTC drugs, medical gases and some non-sterile products. If no report exists, an importer can ask Health Canada for an on-site inspection.
• Renewal: plants outside MRA coverage usually get a "new evidence required by" date about four years after the inspection. A non-compliant rating takes the plant off the licence.

Special access and shortage imports

• Special Access Program (SAP): a practitioner can request a medicine that isn't authorised in Canada, for a patient with a serious or life-threatening condition, when other treatments have failed, don't suit or aren't available. Most requests are processed within one working day. The manufacturer doesn't have to supply, and decides the price.
• Exceptional importation for shortages: when a Canadian product is in a Tier 3 shortage, or another critical one, Health Canada can list a foreign-authorised version for import. Only DEL holders may import it. They must notify Health Canada at least three business days ahead and have a risk communication plan in English and French. Bilingual labels aren't needed. Health Canada consulted on changes from December 2024 to March 2025.
• Urgent public health need: since 2017, public health officials can notify Health Canada of an urgent need. Drugs authorised in certain foreign countries can then be imported for their jurisdiction. The importer reports within 15 days of import.

Pricing

• Patented medicines: the Patented Medicine Prices Review Board checks that prices aren't excessive. Its new guidelines took effect on 1 January 2026.
• Public plans: the pan-Canadian Pharmaceutical Alliance negotiates for public drug plans. Its generic pricing agreement was extended from 1 October 2026 for two years. The deal keeps the tiered pricing framework, which links a new generic's price to the brand price.

Moving medicines between Canada and the US

• Section 804 state programmes: under the 2020 rule, a state or tribe can import certain prescription drugs from Canada. The supply chain is limited to one manufacturer, one Canadian seller licensed by Health Canada and one US importer. Biologics, controlled substances, infused and intravenous drugs are excluded. Every batch is tested and relabelled for the US.
• Current status: the FDA authorised Florida's programme in January 2024 and has extended it several times, most recently in May 2026. Florida's report for the second quarter of 2026 says no drugs have been imported yet, citing manufacturer resistance and Canadian concern about its own supply. The FDA authorised Colorado's programme on 15 June 2026, and the state is still looking for manufacturer partners.
• Canada's export ban: since November 2020, Canadian licence holders can't sell or export prescription drugs meant for the Canadian market if that could cause or worsen a shortage in Canada. Health Canada says it will act immediately against breaches.

What this means for exporters in India, China, Korea, Japan, Europe and the UK

For every exporter

• Register before you ship. FDA registration, a US agent, listings and the right entry codes come before the first US shipment. A Canadian importer with a DEL listing your plant comes before the first Canadian one.
• Be inspection-ready all the time. Unannounced FDA visits are now more common, and an import alert stops a plant's shipments at the border. Our guides to GDP and ICH stability cover two areas inspectors check closely.
• File twice. An FDA approval doesn't give you a Canadian authorisation. Generics still need a full ANDS in Canada, and your US DMF needs a Canadian master file.
• Price in the tariff. Generics are duty-free under Section 232 for now. Patented products carry 0%, 15% or 100% depending on origin and company deals. Check the latest position before you quote.

Exporters in India

• Generics are the opening. They're outside the 2026 tariff, and the ANDA route needs no clinical trials. Watch for any proclamation following the July 2026 announcement on generics.
• Treat FDA compliance as continuous. The unannounced-inspection programme grew out of a pilot in India and China.
• Canada needs its own evidence. India has no GMP MRA with Canada, so the importer files your latest inspection report and renews it before the deadline.

Exporters in China

• APIs and DMFs are the natural way in. US and Canadian generic makers need well-documented API sources, so keep your Type II DMF current and ready for reference.
• Expect closer buyer checks. US policy favours domestic and allied supply, including a 2025 FDA pilot that prioritises ANDAs made and tested in the US with US-made APIs. Our BIOSECURE Act explainer covers the rules on certain biotech suppliers.

Exporters in Korea and Japan

• Biosimilars have a lower bar. Both the FDA and Health Canada have dropped the usual need for comparative efficacy trials, which cuts development cost and time.
• The 15% cap helps. Patented products from Korea and Japan pay 15% instead of 100% under Section 232.
• Check reliance lists. Canada's reliance order doesn't list Korea's or Japan's regulators, so plan for a full Canadian review.

Exporters in Europe and the UK

• Canada is easier on GMP. MRAs with the EU, EEA-EFTA states, Switzerland and the UK mean your regulator's certificate usually covers the plant. EU, Swiss and UK decisions also count under Canada's reliance order, for the medicines it lists.
• US tariffs differ by origin. EU and Swiss patented products pay 15%, while UK products pay 0% for now. Confirm the origin rules for your supply chain.

Trade between Canada and the US

• No shortcut between the two regulators. There's no GMP MRA between Canada and the US, and Canada's reliance order covers few products for now. Each market still needs its own approval.
• Bulk "importation" isn't a business model yet. State programmes have authorisations but no supply, and Canada's export ban stands in the way.

Ready to source for your market?

• Importers, distributors and licence partners in the US and Canada: post your sourcing RFQ. Our RFQ guide shows what to include, and our guide to out-licensing a dossier explains how licence deals are priced.
• Hospitals and patients needing a medicine that isn't approved locally: submit an RFP. Our guide to named-patient import programmes explains how these routes work around the world.
• Clinical teams sourcing comparators: see our guide to comparator sourcing for clinical trials.
• Manufacturers looking to supply North America, whether finished products, APIs or dossiers for licensing: list your company and products so buyers and partners can find you.

This guide summarises public regulations and official sources as of October 2026. US tariff rules in particular are changing fast. Confirm current requirements with the FDA, Health Canada, a customs broker or a regulatory partner before acting.

Sources

• Section 232 investigation of imports of pharmaceuticals and pharmaceutical ingredients (Federal Register, April 2025)
• Proclamation 11020: Adjusting imports of pharmaceuticals and pharmaceutical ingredients (Federal Register, April 2026)
• Fact sheet on tariffs on patented pharmaceutical products (White House, April 2026)
• Tariffs for UK-origin patented pharmaceuticals reduced to zero (International Trade Insights, August 2026)
• US generic drug tariffs: July update (Clinical Leader, July 2026)
• USTR imposes Section 301 forced labour tariffs on 60 economies (Greenberg Traurig, July 2026)
• Abbreviated New Drug Application (FDA, May 2026)
• Determining whether to submit an ANDA or a 505(b)(2) application (FDA guidance, May 2019)
• PDUFA VII performance goals, FY2023–2027 (FDA)
• GDUFA III performance goals, FY2023–2027 (FDA)
• Prescription drug user fee rates for FY2027 (Federal Register, July 2026)
• Generic drug user fee rates for FY2027 (Federal Register, July 2026)
• OTC monograph drug user fee rates for FY2027 (Federal Register, July 2026)
• FDA unveils FY2027 user fee rates, including BsUFA (RAPS, July 2026)
• FDA moves to accelerate biosimilar development (FDA, October 2025)
• FDA takes further steps to streamline biosimilar development (FDA, March 2026)
• ANDA prioritisation pilot for US manufacturing and testing (FDA, October 2025)
• Electronic Common Technical Document (FDA, October 2024)
• How to register a drug establishment (FDA, August 2026)
• Types of drug master files (FDA, May 2025)
• Drug master file fee (FDA)
• Expanded use of unannounced inspections at foreign facilities (FDA, May 2025)
• Importing human drugs (FDA, March 2026)
• Entry review (FDA, January 2026)
• Import alerts (FDA, March 2025)
• DSCSA waivers and exemptions beyond the stabilisation period (FDA)
• DSCSA exemptions for dispensers with 25 or fewer pharmacy staff (FDA, August 2026)
• OTC drug review process and monographs (FDA, October 2023)
• Expanded access (FDA, September 2025)
• Personal importation (FDA, August 2025)
• Section 804 importation programme policies and authorisations (FDA, June 2026)
• Importation of prescription drugs final rule: questions and answers (FDA)
• Canadian Prescription Drug Importation Program, FY2025–26 Q4 report (Florida Agency for Health Care Administration, 2026)
• Canadian prescription drug importation programme (Colorado Department of Health Care Policy and Financing, 2026)
• Guidance: the management of drug submissions and applications (Health Canada, October 2025)
• Fees for examination of a submission: drugs for human use (Health Canada, 2026–27)
• Drug establishment licence fees (Health Canada, 2026–27)
• Ministerial Reliance Order now in force (Smart & Biggar, July 2026)
• Health Canada's draft guidance on foreign regulatory reliance (Fasken, July 2026)
• Health Canada finalises biosimilar guidance (Smart & Biggar, May 2026)
• Guidance on procedures and administrative requirements for master files (Health Canada, January 2024)
• Importing and exporting health products for commercial use, GUI-0117 (Health Canada, July 2026)
• How to demonstrate foreign building compliance with drug GMP, GUI-0080 (Health Canada, July 2025)
• GUI-0080: recommended full GMP evidence (Health Canada, 2025)
• GUI-0080: listing foreign buildings on your DEL (Health Canada, 2025)
• Mutual recognition agreements (Health Canada)
• Special Access Program for drugs: guidance for industry and practitioners (Health Canada, 2022)
• Guide to the exceptional importation and sale of drugs in response to drug shortages, GUI-0148 (Health Canada, July 2026)
• Tier 3 drug shortages (Health Canada, September 2026)
• Access to drugs in exceptional circumstances (Health Canada, August 2024)
• Canada's regulations prevent drugs from being distributed outside the country if this could cause a shortage (Health Canada, February 2024)
• Canada acts to safeguard drug supply (Torys, December 2020)
• PMPRB releases new guidelines (PMPRB, June 2025)
• pCPA generic pricing agreement extended (Canadian Generic Pharmaceutical Association, June 2026)

Frequently Asked Questions(FAQs)

Does the FDA accept approvals from other regulators?

No. Every prescription medicine sold in the US needs its own FDA approval: an NDA, an ANDA, a 505(b)(2) application or a biologics licence. Canada is different. Since July 2026, its Ministerial Reliance Order lets Health Canada rely on US, EU, Swiss and UK decisions for a short list of medicines, though not yet for generics or biosimilars.

Does a foreign manufacturer need a US company to sell in the US?

There's no local licence-holder rule like many other markets have. But every foreign plant must register with the FDA, name a US agent and list its US importers. In practice, most exporters also work with a US partner for distribution, labelling and DSCSA data.

Are generic medicines subject to US pharmaceutical tariffs?

Not at the moment. The Section 232 proclamation of April 2026 exempts generics and biosimilars for now, and Commerce must report within a year on whether to cover them. In July 2026, the President announced plans for generic tariffs from August 2028. No proclamation had been published as of early October 2026.

Who can import medicines into Canada?

A Canadian business with a Drug Establishment Licence for importation, which lists every foreign site that makes, packages or tests the product. Each site needs GMP evidence, such as a certificate under a mutual recognition agreement or a recent inspection report from a regulator.

Can US states import medicines from Canada?

Only under an FDA-authorised Section 804 programme. Florida's programme was authorised in January 2024 and Colorado's in June 2026, but Florida reports that no drugs have been imported yet. Canada also bans exports of medicines meant for Canadians if that could cause or worsen a shortage.