Sourcing Canadian-Registered Medicines for US Clinical Trials and Expanded Access
For US sponsors, CROs and institutions: the IND and expanded-access contexts in which Canadian-registered medicines are lawfully imported, what the importer needs, and why Canada is a practical comparator source.
Two lawful contexts
US law does not permit commercial importation of unapproved drugs for general sale. There are, however, two contexts in which a Canadian-registered medicine is routinely brought into the United States by a sponsor or institution:
1. Investigational use under an IND. A drug used in a clinical investigation is imported under the sponsor's Investigational New Drug application; comparators and background therapies used in the trial are covered by the IND and its labelling requirements in 21 CFR Part 312 [1].
2. Expanded access. FDA may permit an investigational drug to be used outside a trial for a patient or group with a serious condition, through an expanded-access IND or protocol [2].
Separately, FDA has stated a personal importation enforcement policy for individuals; that policy is not a supply route for institutions and is outside this guide [3].
What the US importer of record needs
- An IND or expanded-access authorization number to cite at entry.
- The Canadian regulator record: the Health Canada DPD entry gives the DIN, status, manufacturer and product details in a form FDA and customs brokers recognize [4].
- Certificate of Analysis, batch, expiry, and a temperature record for cold-chain goods.
- Labelling that meets 21 CFR 312.6 (the "Caution: New Drug — Limited by Federal (or United States) law to investigational use" statement) applied by the sponsor or its depot [1].
Why sponsors look to Canada
Bilingual labelling, Health Canada licensing of every establishment in the chain, and a large generic market mean a comparator that is single-source or short in the US often has several marketed Canadian DINs. The molecule's [supply graph](/molecule/adalimumab/suppliers) shows those DINs alongside every other market's registrations.
How Nexara Health supports US sponsors
Nexara Health (Health Canada DEL #3-002896) exports Canadian-marketed product to the sponsor's designated US importer or depot with the documents above. We supply sponsors, CROs and institutions under an IND or expanded-access authorization only; we do not ship to US patients or pharmacies for commercial use. [Request a quote](/contact) or see the [trial comparator supply index](/trials/comparator-supply).
Sources
[1] 21 CFR Part 312, Investigational New Drug Application (incl. § 312.6 labelling, § 312.110 import and export) — https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312
[2] U.S. FDA, Expanded Access — https://www.fda.gov/news-events/public-health-focus/expanded-access
[3] U.S. FDA, Personal Importation — https://www.fda.gov/industry/import-basics/personal-importation
[4] Health Canada, Drug Product Database — https://health-products.canada.ca/dpd-bdpp/