Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Approval of a known active ingredient with a new route, indication, dosage form or dose (Article 14 approval or partial change approval)

Japan · Pharmaceuticals and Medical Devices Agency · New drugs

Full or mixed application, known active substanceHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

What is the Approval of a known active ingredient with a new route, indication, dosage form or dose in Japan?

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. New route of administration, new indication, new dosage form such as extended release, or new dose of an ingredient already approved in Japan.

How much does the Approval of a known active ingredient with a new route, indication, dosage form or dose cost?

The pmda review fee, new route of administration (same band as a new active ingredient) is ¥36,538,400 for Rates in the fee order version in force from 2026-05-01. A reduced fee of ¥30,618,800 applies in some cases (Lower fee for designated orphan drugs).

What are the steps of the Approval of a known active ingredient with a new route, indication, dosage form or dose?

1. File the application through PMDA; 2. Scientific review and compliance survey; 3. Approval by the health minister; 4. Re-examination.

Outcome: Product approval or partial change approval. A product with only a new indication gets a re-examination period of less than six years.

Legal basis: Pharmaceuticals and Medical Devices Act, Article 14(1) and 14(13)

Steps

In order, with the official target for each step

1. File the application through PMDAThe applicant files a new approval application, or a partial change application for an approved product, through PMDA.
2. Scientific review and compliance surveyPMDA reviews the data and checks its reliability. The minister takes PMDA's results into account.
3. Approval by the health ministerThe minister grants the approval or the partial change approval.
4. Re-examinationA drug that differs from approved drugs only in its indication gets a re-examination period of less than six years, set by the minister.

Requirements

What the applicant must provide or meet

Local presence

Marketing authorization holder license in JapanOnly a company with a marketing authorization holder license from the health minister may market drugs. The approval is refused if the applicant does not hold the right license type. The license must be renewed every five years.

Inspection

Licensed or accredited manufacturing sitesEach site that makes the product needs a Japanese manufacturing license, or, for a site outside Japan, accreditation as a foreign manufacturer. The approval is refused if a site lacks this.
GMP compliance inspection(in some cases)For products set by cabinet order, the agency checks manufacturing and quality control by document or site inspection before approval. The check is repeated every five years after approval.

Clinical data

Data set depends on the application categoryThe notice on drug applications lists which data each category needs. A new indication mainly needs clinical and some pharmacology data. A new route also needs quality, stability, absorption and toxicity data. A new dosage form also needs quality, stability and absorption data.
Real-world data in limited cases(in some cases)Since 1 May 2026, for applications such as a new dose where patients are few and clinical trials are hard to run, results from other clinical sources may in some cases replace clinical trial results, if they are scientifically sound.

Other

Dossier format: CTD, filed as eCTD(in some cases)Where an application must include the CTD and electronic study data, the CTD is filed electronically as eCTD through the agency's gateway system.

Language

Japanese languageApplication documents are in Japanese in principle. An English original may be filed together with a Japanese summary.

After approval

Adverse reaction reportingThe marketing authorization holder must report suspected side effects, infections and other safety findings to the health minister.

Official time targets

Targets, not actual review times

No time targets published.

Fees

Official amounts in the local currency

Fee	Amount
PMDA review fee, new route of administration (same band as a new active ingredient)Application · Rates in the fee order version in force from 2026-05-01 · Lower fee for designated orphan drugs.	¥36,538,400reduced ¥30,618,800
PMDA review fee, new indication, dosage or doseApplication · Rates in the fee order version in force from 2026-05-01 · Lower fee for designated orphan drugs.	¥17,438,300reduced ¥14,354,900

Approval of a known active ingredient with a new route, indication, dosage form or dose (Article 14 approval or partial change approval)

What is the Approval of a known active ingredient with a new route, indication, dosage form or dose in Japan?

How much does the Approval of a known active ingredient with a new route, indication, dosage form or dose cost?

What are the steps of the Approval of a known active ingredient with a new route, indication, dosage form or dose?

How the pathway works

Timeline with clock stops

Steps

Requirements

Local presence

Inspection

Clinical data

Other

Language

After approval

Official time targets

Fees

Rule changes