Getting a US-approved medicine in Singapore: the legal route, documents and timing
A sourced guide for patients, families and doctors in Singapore, checked against HSA 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 Singapore, hospitals, clinics and nursing homes need approval from the Health Sciences Authority (HSA) before importing an unregistered therapeutic product for a patient. It is meant for life-saving therapy where no registered option works. Each consignment needs approval and is capped at three months' supply per patient, and the requesting doctor takes full responsibility.
- Regulator: Health Sciences Authority (HSA).
- Main route: Special access route: import and supply of unregistered therapeutic products for patient's use.
- Who applies: A licensed hospital, clinic or nursing home, a licensed retail pharmacy with a valid prescription, or a licensed company acting for them.
- Price: Quote on request.
Who regulates medicines in Singapore
HSA registers therapeutic products in Singapore. It does not assess the safety, quality and efficacy of unregistered products used under the special access route, so the requesting doctor or dentist is fully responsible for their use. HSA is also a partner agency in the US FDA's Project Orbis for cancer medicines.[1, 2]
The legal route for a medicine that is not registered in Singapore
Unregistered therapeutic products should only be considered for life-saving therapy where there is an unmet medical need, for example when no registered option exists and the patient's health will be compromised without the product. Approval is needed for each consignment before import.[1]
Applicants can be a licensed hospital, clinic or nursing home importing for its own doctors' patients; a licensed retail pharmacy acting on a valid prescription; or a company acting for a licensed institution, which needs an importer's and wholesaler's licence with a named pharmacist. Controlled drugs and psychotropic substances need extra licences.[1]
HSA also accepts requests for novel unregistered products that offer a substantive clinical advantage over registered therapies. Investigational products need documented professional consensus under the Singapore Medical Council's ethical guidance.[1]
Documents you will usually need
HSA's conditions for this route include:[1]
- Clinical justification of the unmet medical need and why registered products are not used
- The clinician's documented informed consent from the patient or guardian
- The clinician's declaration that use complies with Ministry of Health practice and applicable law
- The clinician's declaration that use complies with the Singapore Medical or Dental Council's ethical code
- A separate application form (Sections A to E) for each product
Timing, quantities and fees
Each consignment may not exceed three months' supply per patient based on the recommended dose in the package insert. Larger quantities may be considered if substantively justified by medical need. Approval is needed for every consignment.[1]
How a US-approved medicine reaches a patient in Singapore
First, confirm the medicine is approved in the US. FDA's Drugs@FDA database lists approved prescription medicines and links to the approved label.[3]
In Singapore the hospital, clinic or licensed importer applies to HSA for each consignment. We work with the institution's pharmacy, provide the US approval and label documents, and ship from the US through our wholesale partner once HSA approves.
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.[4]
Practical checks before you start
- Ask the treating specialist whether a registered alternative already exists in Singapore. 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 Singapore
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 hospital in Singapore import a medicine that HSA has not registered?
Yes, with HSA approval for each consignment under the special access route, for life-saving therapy where no registered option meets the patient's need.
How much can be imported at once?
Up to three months' supply per patient per consignment, based on the label dose, unless a larger amount is substantively justified.
Who is responsible for the unregistered product?
The requesting doctor or dentist. HSA does not assess the product's safety, quality and efficacy under this route.
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.
- Health Sciences Authority Singapore: Import and supply of unregistered therapeutic products for patient's use (accessed 17 October 2026)
- US FDA Oncology Center of Excellence: Project Orbis (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.