Getting a US-approved medicine in Taiwan: the legal route, documents and timing
A sourced guide for patients, families and doctors in Taiwan, checked against MOHW and TFDA rules on 17 October 2026.
Reviewed by the Reserve Meds clinical operations team on 17 October 2026. Sources accessed 17 October 2026.
The short answer
In Taiwan, a medicine without a Taiwanese licence can be approved case by case for import under the Ministry of Health and Welfare's special-case regulations of 8 September 2016. They apply to life-threatening or severely disabling diseases with no suitable domestic medicine or alternative, and to public health emergencies. The application is made through the treating hospital.
- Regulators: Ministry of Health and Welfare (MOHW) and the Taiwan Food and Drug Administration (TFDA).
- Main route: Special-case (專案) approval for import of an unlicensed medicine.
- Who applies: The medical institution treating the patient.
- Price: Quote on request.
Who regulates medicines in Taiwan
Medicines in Taiwan must be reviewed and licensed before patients can use them. The Ministry of Health and Welfare recognises that new medicines can treat serious diseases before they are licensed in Taiwan, and issued special-case regulations so that, after professional assessment of the patient, an unlicensed medicine can be used.[1]
The legal route for a medicine that is not registered in Taiwan
On 8 September 2016 the Ministry issued the Regulations for Approval of Special Manufacture and Import of Medicines. They cover the prevention or treatment of life-threatening or severely disabling diseases for which there is no suitable medicine or alternative therapy in Taiwan, and public health emergencies, where an unlicensed medicine is needed.[1]
The authority can require the applicant to submit safety or efficacy reports on the approved medicine within a set period, and will revoke the approval if a licensed medicine or suitable alternative becomes available, if the emergency ends, or if there are safety or efficacy concerns.[1]
Documents you will usually need
The Ministry's announcement does not list the forms. Our checklist for the hospital (the TFDA may ask for more):
- The treating physician's assessment of the patient and why no domestic alternative is suitable
- The hospital's application for special-case import of the named medicine and quantity
- Evidence of the medicine's approval abroad, such as the US FDA approval and label
- The patient's informed consent, under the hospital's own procedures
Timing, quantities and fees
The Ministry's announcement does not give a processing time. Approvals can carry reporting duties and can be revoked when a licensed alternative appears.[1]
How a US-approved medicine reaches a patient in Taiwan
First, confirm the medicine is approved in the US. FDA's Drugs@FDA database lists approved prescription medicines and links to the approved label.[2]
In Taiwan the treating hospital applies for special-case import approval. We work with the hospital pharmacy, provide the US approval and label documents, and ship from the US through our wholesale partner once approval is granted.
Once the local permission is in place, the medicine is bought from the US supply chain, packed for the temperature the label requires, and shipped to the named hospital, clinic or importer with the documents customs will ask for. Cold-chain medicines need a validated shipper and a temperature record for the whole journey.
If the medicine is a cell or gene therapy, the rules are different: these are usually given only at qualified treatment centers chosen by the manufacturer, so the realistic route is often treatment at a center abroad rather than import.[3]
Practical checks before you start
- Ask the treating specialist whether a registered alternative already exists in Taiwan. Most special routes only apply when it does not.
- Check whether the medicine is a controlled drug. Controlled medicines need extra permits in almost every country.
- Ask the hospital pharmacy whether it has handled this route before and who signs the application.
- Keep copies of every document and approval. Customs and the hospital will ask for them again at delivery.
How Reserve Meds helps
Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help families and treating doctors understand the route, prepare the documents the regulator or hospital asks for, arrange supply from the US once approval is in place, and keep everyone updated. We do not diagnose, prescribe or decide what a regulator approves.
We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.
Ask us about a medicine for a patient in Taiwan
Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.
Frequently asked questions
Can a patient in Taiwan get a medicine that is not licensed there?
Yes, case by case, under the Ministry of Health and Welfare's special-case manufacture and import regulations for life-threatening or severely disabling diseases with no suitable domestic alternative.
When did Taiwan's special-case import rules start?
The Ministry of Health and Welfare issued them on 8 September 2016.
Can a special-case approval be withdrawn?
Yes. It is revoked if a licensed medicine or suitable alternative becomes available, an emergency ends, or safety or efficacy concerns arise.
Does Reserve Meds apply to the regulator for us?
No. The application is made by the person or institution the rules name, usually the treating doctor or hospital. We help prepare the paperwork, confirm the US approval and arrange supply from the US once permission is granted.
How much does it cost?
Quote on request. The total depends on the medicine, the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.
Sources for these answers: [1]
Sources
All sources were opened and checked on 17 October 2026. Rules and labels change, so the treating hospital or regulator confirms the current position before anything is filed.
- Ministry of Health and Welfare Taiwan: Regulations for Approval of Special Manufacture and Import of Medicines (特定藥物專案核准製造及輸入辦法) (accessed 17 October 2026)
- US FDA: How do I find out if a drug is approved? (accessed 17 October 2026)
- US FDA: Approved Cellular and Gene Therapy Products (accessed 17 October 2026)
Related
- All country guides
- Named-patient access, explained
- US expanded access (compassionate use)
- Answers to common access questions
- How cold-chain medicines are shipped
This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.