Question 1

What does Assyro support for PMDA submissions?

Accepted Answer

Assyro supports submissions to the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. Your Japanese filing runs in the same workspace as your FDA, Health Canada, and EMA submissions. Book a demo to walk through your Japanese program.

Question 2

What is the PMDA?

Accepted Answer

The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's regulatory agency for pharmaceuticals, biologics, regenerative medicine products, and medical devices. PMDA conducts the scientific review, and the Ministry of Health, Labour and Welfare (MHLW) grants the approval. Japan is a founding member of the International Council for Harmonisation (ICH).

Question 3

How is a Japanese eCTD submission structured?

Accepted Answer

Like other ICH regions, Japan uses a regional Module 1 for administrative and product information, while Modules 2 to 5 follow the ICH Common Technical Document (CTD) structure.

Question 4

How does Japan's approval process compare to FDA's?

Accepted Answer

In broad terms it follows the same two stages. A sponsor notifies PMDA of a clinical trial plan before the trial starts in Japan. To market the product, the sponsor applies for approval, PMDA reviews the application, and MHLW grants approval. Timelines, data requirements, and local steps differ, so confirm the current requirements for your product with PMDA guidance or a Japanese regulatory partner.

Question 5

Is a Japanese clinical trial notification the same as an FDA IND?

Accepted Answer

They serve a similar purpose. A sponsor submits a clinical trial notification to PMDA before starting a trial in Japan, and the first notification for a new active ingredient carries a 30-day review period before the trial may begin, similar to the 30-day wait after an FDA IND.

Question 6

What is a PMDA consultation?

Accepted Answer

PMDA offers formal consultations where a sponsor can discuss a development program, a clinical trial plan, or an upcoming application with PMDA reviewers before filing. They play a similar role to FDA's formal meetings. Consultations are requested in advance and carry a fee.

Question 7

How long does a PMDA review take?

Accepted Answer

PMDA publishes review time targets for new drug applications, around 12 months for standard review and 9 months for priority review, measured from submission to approval. Actual times vary by product and application, so check PMDA's current performance reports for your planning.

Question 8

What goes in the Japanese Module 1?

Accepted Answer

Module 1 holds Japan-specific administrative documents, such as the application form and the draft package insert, and is prepared in Japanese. Modules 2 to 5 follow the ICH CTD structure shared with other regions, which is why much of the content can be reused from an FDA or EMA filing.

Question 9

Can we manage PMDA, FDA, Health Canada, and EMA submissions in one place?

Accepted Answer

Yes. Your Japanese submission sits in the same Assyro workspace as your FDA, Health Canada, and EMA submissions for the same program, so one team sees every filing.

Question 10

Does Assyro decide what we file with PMDA?

Accepted Answer

No. AI drafts, checks, and triages the work. Your regulatory professionals review it and decide what is submitted to PMDA.

Question 11

How do we start a PMDA submission with Assyro?

Accepted Answer

Book a demo with your program details: the product, the submission type, and your target filing date. We walk through how Assyro handles your Japanese submission.

Japan PMDA eCTD Submissions, Coordinated in One Workspace

PMDA Filing Workflow

Japan in the Same Workspace

Clear Owners for Every Japanese Task

Status Without the Rebuild

Decisions You Can Find Again

PMDA Filing Controls and Capacity

Maintain Audit-Ready PMDA Records

Manage More PMDA Programs With the Same Team Size

Guides for your next decision

Questions About PMDA Submission Software

See Your Japanese Submission in Assyro.