Supplying Medicines and Supplements to Japan

Japan reviews every medicine in full. A licensed marketing authorisation holder answers for the product, every overseas plant must be accredited, and the application has to be in Japanese. Once approved, the NHI price list decides what the medicine earns. Japan also wants more medicines approved earlier, so overseas companies now get free English advice and a pricing reward for filing early.

Japan is also a strong place to source from. Many originator medicines were first developed there, and plants work under PMDA GMP inspection within the PIC/S system. API makers can keep their process data confidential in a PMDA master file. For exports, MHLW issues certificates such as a certificate of pharmaceutical product and a GMP certificate, after PMDA checks the application.

Japan at a glance

How to supply medicines to Japan

1. Choose who holds the approval. A Japanese company with a marketing business licence holds the approval, or you hold it yourself under the foreign exceptional approval route and appoint a designated MAH. The MAH carries the legal risk, so expect close checks on your quality system. Our Japan, Korea, Australia and New Zealand guide explains each role.
2. Get your plants accredited and your API file in place. Every overseas plant making the medicine or its API needs foreign manufacturer accreditation, which takes about five months. API makers can register a master file with PMDA through an in-country caretaker. See CEP vs DMF vs ASMF and our API sourcing service.
3. File the dossier in Japanese. Use the ICH CTD with a Japanese Module 1. A generic needs bioequivalence, the original's re-examination period must have ended, and MHLW looks closely at stability, specifications and impurities (see ICH stability guidelines). Our dossier and registration service can help with licensed dossiers.
4. Pass GMP inspection and get listed. PMDA checks GMP at approval and about every five years after. Plants in MRA or MOU countries can submit their own regulator's certificate. Reimbursed medicines then go on the NHI price list, and a new generic usually starts at half the original price.

Unapproved medicines can't be sold in Japan. A doctor bringing one in for a patient needs an import confirmation from an MHLW regional health bureau before the shipment arrives. See named-patient and special import and government tender supply.

Sourcing from Japan

• Originator medicines and comparators. When a trial needs the Japanese-approved version of a medicine, source it through licensed channels and ask for batch certificates, the Japanese package insert and cold-chain records. Our comparator supply service and comparator sourcing guide cover blinding and documents.
• APIs and master files. Japanese API makers can hold a master file with PMDA, and Japan has been a PIC/S member since 2014. GMP certificates are issued by MHLW, not PMDA. Ask which file supports your market and read our DMF guide for the questions to ask.
• Contract manufacturing. Japanese plants work under PMDA GMP inspection, which suits partners who need well-documented quality systems. Plan for longer lead times and detailed technical agreements. See our CDMO guide and white-label manufacturing.
• Export documents. MHLW issues certificates for exported medicines, including a certificate of pharmaceutical product and a GMP certificate, after PMDA checks the application. Ask the Japanese holder which ones your regulator needs. See our CoPP guide and documentation and quality pack.

Supplements

Supplements are sold as foods in Japan. Foods with nutrient function claims can carry set vitamin and mineral claims without notification, foods with function claims must be notified to the Consumer Affairs Agency before launch and now need GMP, and FOSHU products need the Agency's permission. Imported foods need an import notification at an MHLW quarantine station, some ingredients count as medicines whatever the label says, and you should keep disease claims off the pack. We help brands get supplements made under their own label by GMP-certified contract manufacturers: see nutraceutical private label.

What people in Japan search for

Semrush data from October 2026 shows that people in Japan search most for ビタミン d (vitamin D, about 201,000 searches a month), グミ (gummies, 135,000, though many are for sweets), ビタミン b and ビタミン c (vitamin B and vitamin C, 110,000 each) and ビタミン b12 (vitamin B12, 90,500).

Medicine-related searches in Japan are mostly vitamins too: ビタミン c, ビタミン d and ビタミン e get about 18,100 a month each, and mct オイル (MCT oil) 14,800. Searches by generic name are few, with ivermectin at about 320.

How importers, pharmacies and manufacturers in Japan search

Trade searches are in English: “private label” gets about 720 a month and “contract manufacturing” about 140. Other private label searches are for bags and school bags rather than health products.

Supplements we can help you make

Searches in Japan are mostly for vitamins and supplements; ivermectin is the medicine name searched most. Some medicines we list:

日本語版: 日本・韓国・オーストラリア・ニュージーランドへの医薬品輸入ガイド（2026年）

Documents to ask your supplier for

• A Certificate of a Pharmaceutical Product (CoPP) in WHO format.
• The plant's GMP evidence, such as a WHO-GMP, EU-GMP or PIC/S certificate, plus any inspection by your regulator.
• The registration dossier (CTD or ACTD), with bioequivalence data for generics where required.
• Stability data for hot climates.
• A Certificate of Analysis for every batch.

Not sure a supplier is genuine? Read how to verify a pharmaceutical supplier. For the neighbouring markets, see our Japan, South Korea, Australia and New Zealand import guide.

Frequently asked questions