Approval routes, expedited programs and designations, with steps, official time targets, fees and reliance. Last verified October 3, 2026.
Routes on this page
24
Reviewed
Product types
9
Drugs, devices and more
Shortest review target
122 days
Approval of a generic (equivalent) medical device
Approvals in the data
0
Official regulator data
Japan has 24 reviewed approval routes and programs on this page. The main routes for new medicines are Approval of a drug with a new active ingredient, Approval of a known active ingredient with a new route, indication, dosage form or dose, Approval of a regenerative medical product (cell or gene therapy).
Among the routes with an official review target, Approval of a generic (equivalent) medical device has the shortest target: 122 days. Targets are not actual review times.
Yes. Fast priority review of a product already sold abroad during a supply shortage relies on CA, DE, FR, GB, US; Special approval for emergencies (based on foreign approval) relies on CA, DE, FR, GB, US.
11 routes
A drug with an active ingredient that is not in any approved drug needs product approval from the health minister. The agency PMDA reviews the full quality, nonclinical and clinical data. Vaccines and other biologics follow the same route.
Full application, new active substance · target 365 days · verified October 3, 2026
A drug that uses an approved active ingredient but changes the route, the indication, the dosage form or the dose needs approval. A change to an approved product needs a partial change approval. The data needed is smaller than for a new active ingredient.
Full or mixed application, known active substance · verified October 3, 2026
A company that makes a product abroad for export to Japan can hold the approval itself. It must appoint a licensed marketing authorization holder in Japan, which markets the product and takes safety measures in Japan. The review is the same as for a domestic application.
Other route · verified October 3, 2026
The health minister may review a product ahead of others when it is an orphan, pioneering or specific-use product, or another product with a high medical need. A new product for a serious disease that is clearly better than existing options can also qualify. The PMDA target for priority new drugs is shorter than for standard ones.
Priority or accelerated review · target 274 days · verified October 3, 2026
When an approved drug is in short supply and there is no other suitable treatment, the minister may review, ahead of all others, a product that is the same as the approved drug and is allowed for sale in a listed country. For drugs the listed countries are the United States, the United Kingdom, Canada, Germany and France. For devices and IVDs it is the United States.
Reliance route, abridged review · relies on CA, DE, FR, GB, US · verified October 3, 2026
A drug, device or IVD with a high medical need, such as an orphan or pioneering product, can be approved when its efficacy can be reasonably predicted. The approval requires studies after approval. The holder files the results and the minister checks the product again.
Conditional or accelerated approval · verified October 3, 2026
The health minister can designate a drug, device or regenerative product as pioneering when its mechanism or principle clearly differs from products approved in Japan or abroad and it is expected to be especially useful. Designated products get priority review, can qualify for conditional approval, and drugs can get a longer re-examination period. The PMDA target is a total review time of about 6 months.
Intensive development support designation · target 183 days · verified October 3, 2026
The health minister designates drugs, devices and regenerative products for diseases with fewer than 50,000 patients in Japan and a high medical need. Designated products can get grants, guidance, a tax credit, priority review, lower review fees for drugs, and a 10 year re-examination period for drugs and regenerative products.
Orphan or rare disease designation · verified October 3, 2026
The health minister can designate a product for diseases in categories the minister sets, where demand for such products is far from met and the product would be especially useful. Designated products can get priority review and can qualify for conditional approval.
Other route · verified October 3, 2026
In a health emergency, the minister can approve a drug set by cabinet order that is urgently needed, has no suitable alternative, and is allowed for sale in a listed country. Some normal review and inspection rules do not apply. The cabinet order currently covers drugs for COVID-19.
Emergency or temporary authorisation · relies on CA, DE, FR, GB, US · verified October 3, 2026
In a health emergency, the minister can approve a drug set by cabinet order when efficacy is presumed and the drug is urgently needed with no suitable alternative. The approval has conditions and a time limit of up to two years, which can be extended by up to one year. The holder must file a new full application within the time limit.
Emergency or temporary authorisation · verified October 3, 2026
1 routes
A biosimilar is a biotechnology medicine developed by a different company to have quality, safety and efficacy equivalent to an approved original biologic. Approval rests on comparison data. A clinical trial on efficacy is needed when quality and PK or PD data are not enough to conclude equivalence.
Biosimilar application · verified October 3, 2026
1 routes
A generic prescription drug needs product approval like any other drug, but with a smaller data set. The agency checks quality and bioequivalence with the original product. Makers of prescription drugs must report planned supply stops.
Generic application · target 304 days · verified October 3, 2026
1 routes
Non-prescription drugs need product approval. Products with an ingredient, route, indication, form or dose new to the non-prescription market, such as switches from prescription use, need more data and a longer review. Products that match an approval standard need little data.
Non-prescription application · target 365 days · verified October 3, 2026
2 routes
Processed human or animal cells and gene therapy products form their own product type, regenerative medical products. Each product needs approval from the health minister after PMDA review. Manufacturing quality is always checked before approval.
Full application, new active substance · target 365 days · verified October 3, 2026
A regenerative medical product that is not uniform in quality can be approved early when efficacy is presumed and it is not presumed to be too harmful. The approval has conditions and a time limit of up to seven years, which can be extended by up to three years. The holder must file a new full application within the time limit.
Conditional or accelerated approval · verified October 3, 2026
1 routes
There is no separate route for combination products. Each combination product is filed as one product, either a drug, a device or a regenerative product, judged by its main function and purpose. Its components do not need their own approvals.
Other route · verified October 3, 2026
5 routes
General medical devices (Class I) and IVDs that do not need approval or certification are notified before marketing. There is no review. The maker must hold a marketing license and notify changes within 30 days.
Device: premarket notification · verified October 3, 2026
Class II and some Class III devices, and some IVDs, that meet a standard set by the health minister are certified by a registered certification body instead of being approved by the minister. The body checks conformity with the standard and the quality system. Products that do not fit a standard go to approval.
Device: conformity assessment by a certification body · verified October 3, 2026
A device that clearly differs from approved devices in structure, use, effect or performance needs approval from the health minister after PMDA review. The council is consulted. New devices can be designated for use-results evaluation after approval.
Device: premarket approval by the regulator · target 426 days · verified October 3, 2026
A device that is neither new nor equivalent to an approved device needs approval after PMDA review. Review targets differ for files with and without clinical data.
Device: premarket approval by the regulator · target 304 days · verified October 3, 2026
A device that is the same as an approved device in structure, use, effect and performance, but is not covered by a certification standard, needs approval after PMDA review. Fees are lower when an approval standard exists.
Device: premarket approval by the regulator · target 122 days · verified October 3, 2026
1 routes
IVDs are drugs used only for diagnosis that are not used directly on the body. In Japan they follow the device chapter of the law. IVDs that are not covered by notification or certification need approval from the health minister after PMDA review.
Device: premarket approval by the regulator · target 213 days · verified October 3, 2026
1 routes
Software that is a medical device is regulated as a device and needs approval, certification or notification by risk. Under ministry guidance, software can first be approved for a limited purpose that current data can show. After clinical evidence builds up in use, the holder applies for a partial change approval to expand the claims.
Other route · verified October 3, 2026
Recent changes and pending reforms
Compare Japan with: United States, European Union, United Kingdom, China, Germany, France, Italy, Spain.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.