PMDA Consultation Fees & Timelines (FY2026)

By e-mail to PMDA's Office of Review Management, using PMDA's Japanese forms. Most drug, regenerative and RS strategy consultations go through the monthly intake described above; procedural and expanded-trial consultations and priority products are accepted any time. Device and IVD consultations start with a scheduling request to the device desk, often after a JPY 29,400 preparatory interview. Links to every form are on the PMDA consultation page.

The meeting is run by PMDA in Japanese. PMDA meeting rooms have a simultaneous-interpretation booth, but the interpreter must be arranged by you, and you must tell PMDA beforehand whether foreign attendees and interpreters will join. Web meetings are possible on request. Whether briefing materials may be submitted in English differs by category: some forms ask for English documents in addition to Japanese ones, but we have not confirmed a general rule, so ask PMDA at the pre-meeting (unverified).

For a drug entering humans for the first time, the category is the “consultation before start of phase I study” (JPY 4,578,500, orphan JPY 3,441,000). If the drug already has foreign data and you plan to go straight into a Japanese or global trial, companies often use the phase II-stage categories instead; the free pre-meeting is the place to confirm the category. Separately, the first clinical trial notification for a new active ingredient (and new route or new combination) triggers a 30-day review: the trial cannot start until 30 days after notification (PMDA).

A foreign company without a Japanese entity normally works through a Japanese company: a designated marketing authorisation holder (DMAH, 選任製造販売業者) for a foreign-manufacturer approval, and an in-country clinical trial caretaker for trials. In practice that partner or a Japanese consultant handles the Japanese forms, the fee payment from a Japanese bank account, and the meeting. Fee payment requires a 9-digit business code; applicants without one use a placeholder code set by PMDA. (Role summary is general background, not taken from the fee documents.)

Yes, in two places: RS strategy consultations (about 90% off for qualifying universities and ventures) and the SaMD multi-session package, which is currently a pilot limited to academia and ventures with 20 or fewer employees. For devices, IVDs and regenerative products there is also a 50% fee subsidy for qualifying SMEs. We have not confirmed whether a company without a Japanese entity can qualify (unverified).

PMDA revises parts of the table from time to time. The current consultation table is dated 29 May 2026; PMDA's fee page notes a revision on 31 March 2026. Review-fee tables were last revised in May 2022. We check PMDA's fee pages monthly and update this page when they change.