When a patient in China needs a medicine that is not yet available on the local market — an orphan drug, a named-patient product, or another hard-to-find treatment — the question is how to obtain it through a compliant, traceable route. GNH USA is a US-based, WHO GDP-certified pharmaceutical distributor that serves patients and healthcare providers worldwide. We source unlicensed, orphan and named-patient medicines from regulator-approved markets and arrange their supply toward China, working alongside the clinicians, institutions and importers who carry local responsibility and operate subject to NMPA requirements.
China regulatory context
How imported and not-yet-approved medicines work in China
NMPA oversight
The National Medical Products Administration sets the requirements for approving, importing and supplying medicines in China.
Clinically urgent imports
China provides a pathway for clinically urgently needed imported drugs, intended for serious conditions where a suitable approved option is lacking, subject to NMPA requirements.
Hainan Boao Lecheng
The Hainan Boao Lecheng International Medical Tourism Pilot Zone permits the use of certain not-yet-approved imported drugs and devices at designated institutions within the zone.
Orphan and rare disease
Orphan medicines treat rare conditions for which a locally approved product may not exist; named-patient routes can help individual patients access them.
Clinical responsibility
Use is overseen by the treating clinician and the receiving institution, who take responsibility for the patient in line with local rules.
Documented supply
Each supply is supported by documentation so the clinical and regulatory basis for import and use can be demonstrated.
China's framework recognises that a single national approval list cannot meet every patient's needs at every moment. Two features matter most for hard-to-find medicines. First, there is a pathway for clinically urgently needed imported drugs, intended for serious or life-threatening conditions where an approved domestic option is absent or unsuitable; access through this route is subject to NMPA requirements and to the judgement of the treating institution. Second, the Hainan Boao Lecheng International Medical Tourism Pilot Zone allows designated institutions within the zone to use certain imported drugs and medical devices that have not yet completed full national approval, under defined conditions.
GNH USA's role is to sit on the supply side of these routes: to identify a suitable regulator-approved source, handle the product under WHO GDP-certified conditions, and deliver it with the documentation that a Chinese institution, importer or clinician needs to satisfy the applicable pathway. The clinical and regulatory decisions remain with the local parties; we make the global sourcing and logistics dependable.
You can request a medicine at any time, or read more about our named-patient supply service and how we support clinicians and patients worldwide.
The process
From request to delivery toward China
- Step 01
Request
A clinician, hospital, importer or caregiver tells us the medicine required and the clinical context.
- Step 02
Verification
We confirm the order and the documentation that the applicable China pathway requires, subject to NMPA requirements.
- Step 03
Sourcing
We identify a suitable, regulator-approved source for the product worldwide.
- Step 04
Import and QA
Importation is arranged with the local importer or institution, with internal quality checks before release.
- Step 05
Delivery
The medicine ships via validated, temperature-controlled lanes under WHO GDP to the receiving institution.
Medicine request
Request an orphan or named-patient medicine for China
Sourced worldwide
From regulator-approved markets toward the institution or importer in China.
NMPA-aligned
Import and supply handled subject to NMPA requirements and the applicable pathway.
WHO GDP cold-chain
Temperature-sensitive medicines ship via validated, monitored lanes.
Request a medicine
FAQ
Frequently asked questions
How can a not-yet-approved medicine reach a patient in China?
China provides recognised routes for medicines that do not yet hold full national approval. These include a pathway for clinically urgently needed imported drugs and the use of certain not-yet-approved imported products at designated institutions within the Hainan Boao Lecheng International Medical Tourism Pilot Zone. Each route is subject to NMPA requirements and local institutional oversight.
What is the NMPA?
The NMPA is the National Medical Products Administration, the authority that regulates the approval, importation and supply of medicines in China. Imported medicines generally require NMPA approval, with defined exceptions for urgently needed and pilot-zone use.
What is the Hainan Boao Lecheng pilot zone?
The Hainan Boao Lecheng International Medical Tourism Pilot Zone is a designated area where authorised institutions may use certain imported drugs and medical devices that have not yet completed full national approval, under defined conditions. It is one of the recognised routes for accessing newer treatments in China.
Who can request an orphan or named-patient medicine for China?
Requests are made in connection with the treating clinician and the receiving hospital or importer, who take clinical and regulatory responsibility locally. Caregivers and pharmacies can start an enquiry, and the supply proceeds in line with the applicable pathway.
How does GNH USA source these medicines?
GNH USA is a US-based, WHO GDP-certified distributor that sources orphan, named-patient and other hard-to-find medicines from regulator-approved markets worldwide, then arranges compliant, temperature-controlled delivery toward China with full documentation, subject to NMPA requirements.
How long does the process take?
Timelines depend on the medicine, its source, the chosen pathway and the documentation involved. We respond to enquiries within one business day and confirm the expected route once the request is verified.
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