Getting a US-approved medicine in Japan: the legal route, documents and timing
A sourced guide for patients, families and doctors in Japan, checked against MHLW 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
Japan lets individuals import medicines for personal use, but above set amounts you need an Import Confirmation from the Ministry of Health, Labour and Welfare before travel or shipment. Prescription drugs and injectables up to one month's supply do not need it. Narcotics and stimulants are controlled by other laws and cannot be brought in this way.
- Regulator: Ministry of Health, Labour and Welfare (MHLW), with the PMDA reviewing approvals.
- Main route: Personal import with an Import Confirmation (yakkan shoumei) where required.
- Who applies: The individual patient or traveller.
- Price: Quote on request.
Who regulates medicines in Japan
Importing medicines into Japan is controlled by the Pharmaceutical and Medical Device Act and the Customs Law, to prevent harm from defective products. Japan's own approval system includes the SAKIGAKE designation for innovative products.[1, 2]
The legal route for a medicine that is not registered in Japan
To bring medicines for personal use into Japan above the set amounts, you apply for Import Confirmation, receive it before you leave home, and show it to customs. Some personal import procedures can now be applied for online.[1]
- Prescription drugs, and poisons or deadly poisons: up to one month's supply without Import Confirmation.[1]
- Injectable drugs and their syringes: up to one month's supply without Import Confirmation.[1]
- Non-prescription drugs for external use: up to 24 per item.[1]
Prohibited drugs and controlled drugs cannot be brought in under these rules, and narcotics and stimulant raw materials are subject to separate laws.[1]
A medicine given in a Japanese hospital that is not approved in Japan follows the hospital's own procedures and Japanese law; the treating doctor and hospital confirm what is allowed.
Documents you will usually need
MHLW's Q&A for importers sets out the exact requirements. Our checklist for preparing an Import Confirmation application:[1]
- The application for Import Confirmation (online where available)
- A copy of the prescription or a doctor's statement for the medicine
- Product details: name, quantity and purpose
- Your travel or shipping details
Timing, quantities and fees
Apply before you travel or ship: the Import Confirmation must be received before departure and shown at customs. Amounts within the one-month limits do not need it.[1]
How a US-approved medicine reaches a patient in Japan
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]
For Japan, a personal import is in the patient's name. We check whether an Import Confirmation is needed for the quantity, help prepare the prescription details, and ship from the US through our wholesale partner to the patient or the treating hospital as the rules allow.
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 Japan. 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 Japan
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
How much prescription medicine can I bring into Japan without paperwork?
Up to one month's supply of prescription drugs, and up to one month's supply of injectables and their syringes, without an Import Confirmation.
What is the yakkan shoumei?
It is the Import Confirmation from MHLW that you need for personal-use medicines above the set amounts. You receive it before departure and show it at customs.
Can I bring narcotics or stimulants into Japan with a prescription?
Not under the personal import rules. They are controlled by separate laws, so check MHLW's guidance before travelling.
Does Reserve Meds apply to the regulator for us?
No. The patient or traveller applies to MHLW for Import Confirmation where it is needed. We help prepare the details and arrange US supply.
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, Labour and Welfare Japan: Information for those who are bringing medicines for personal use into Japan (accessed 17 October 2026)
- PMDA Japan: Strategy of SAKIGAKE by MHLW (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.