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Guides on importing unapproved and specialty medicines: named patient access, regulatory pathways and compliance requirements.

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Global Access to Unapproved Drugs
Import09 Dec 2025

Global Access to Unapproved Drugs

In some scenarios, patients around the world need unlicensed or unapproved medicines. This happens when standard treatments have failed or are not yet available in their home country. Healthcare is changing quickly, and Global Access to Unapproved Drugs is becoming important, as new medicines are approved every year by authorities like the U.S. FDA, EMA,

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