Reference · FY2026 · Last checked 2026-09-26
What each PMDA meeting category costs, in yen and approximate US dollars, and how long it takes to get the meeting and the minutes. Covers drugs, medical devices, in vitro diagnostics, SaMD and regenerative medical products. Every fee is copied from PMDA's official Japanese fee table and linked to its source.
55 of the most-used categories. PMDA's full table has several hundred lines (orphan variants, “additional consultation” and “after preparatory interview” prices, GLP inspections, certificates). Rows marked unverified* have one element we could not confirm in an official English source: hover to see which. Fees themselves are all checked against the Japanese table.
| Consultation (EN / JA) | Fee (JPY / ~USD) | Timeline | Notes | Source |
|---|---|---|---|---|
| Pre-consultation meeting (drugs), no record 医薬品事前面談 unverified* | Free per meeting | Free pre-meeting details | Free. Max 20 min, normally up to 5 attendees. PMDA does not evaluate data and makes no record. Used to scope questions before a paid consultation. | PMDA |
| Procedural consultation for drugs 医薬品手続相談 | ¥150,900 ~$960 per consultation | Rolling intake details | Procedures only, no data evaluation. About 30 min. Accepted any time (outside the monthly intake). | PMDA |
| Consultation before start of phase I study (non-orphan) 医薬品第Ⅰ相試験開始前相談（オーファン以外） | ¥4,578,500 ~$29,050 per consultation | Monthly intake details | First advice on first-in-human use and phase I design. Orphan: JPY 3,441,000. | PMDA |
| Consultation before start of early phase II study (non-orphan) 医薬品前期第Ⅱ相試験開始前相談（オーファン以外） | ¥1,752,800 ~$11,120 per consultation | Monthly intake details | Dose-finding in a small number of patients. Orphan: JPY 1,320,200. | PMDA |
| Consultation before start of late phase II study (non-orphan) 医薬品後期第Ⅱ相試験開始前相談（オーファン以外） | ¥4,784,300 ~$30,360 per consultation | Monthly intake details | Orphan: JPY 3,592,900. | PMDA |
| Consultation after completion of phase II study (non-orphan) 医薬品第Ⅱ相試験終了後相談（オーファン以外） | ¥9,497,400 ~$60,270 per consultation | Monthly intake details | End-of-phase-II type meeting on the pivotal (phase III) design. Orphan: JPY 7,134,300. | PMDA |
| Pre-application consultation for drugs (non-orphan) 医薬品申請前相談（オーファン以外） | ¥9,497,400 ~$60,270 per consultation | Monthly intake details | Pre-NDA: format and sufficiency of the application package. Orphan: JPY 7,130,100. | PMDA |
| Additional consultation for drugs (non-orphan) 医薬品追加相談（オーファン以外） | ¥2,889,700 ~$18,340 per consultation | Monthly intake details | 2nd and later consultation at the same development stage. Orphan: JPY 2,171,200. | PMDA |
| Quality consultation for drugs 医薬品品質相談 | ¥1,596,500 ~$10,130 per consultation | Monthly intake details | CMC: specifications, stability, manufacturing. | PMDA |
| Safety consultation for drugs 医薬品安全性相談 | ¥1,925,300 ~$12,220 per consultation | Monthly intake details | Non-clinical (PK, pharmacology, toxicology). | PMDA |
| Consultation on bioequivalence testing, etc. for drugs 医薬品生物学的同等性試験等相談 | ¥600,400 ~$3,810 per consultation | Monthly intake details | PMDA | |
| Consultation before the start of expanded clinical trials for drugs 医薬品拡大治験開始前相談 | ¥261,500 ~$1,660 per consultation | Rolling intake details | Expanded-access trials. Accepted any time. A subsidised fee of JPY 26,150 applies while a state subsidy programme lasts. | PMDA |
| Prior assessment consultation for drugs (phase I study) 医薬品事前評価相談（第Ⅰ相試験） | ¥5,505,400 ~$34,930 per consultation | Type-specific details | Pre-review of data before filing; runs on its own timetable. | PMDA |
| Prior assessment consultation for drugs (phase II/III study) 医薬品事前評価相談（第Ⅱ相／第Ⅲ相試験） | ¥11,036,500 ~$70,030 per consultation | Type-specific details | The largest single consultation fee in the table. | PMDA |
| Consultation on drug product eligibility for priority review 医薬品優先審査品目該当性相談 | ¥1,300,600 ~$8,250 per consultation | Type-specific details | JPY 266,400 if combined with a pre-application consultation. | PMDA |
| Consultation on drug product eligibility for conditional approval 医薬品条件付承認品目該当性相談 | ¥1,016,100 ~$6,450 per consultation | Type-specific details | JPY 208,200 if combined with a pre-application consultation. | PMDA |
| Consultation on R&D plan for pediatric drugs 小児用医薬品開発計画確認相談 | ¥1,541,600 ~$9,780 per consultation | Type-specific details | PMDA | |
| Consultation on pharmacogenomics/biomarkers (qualification) ファーマコゲノミクス・バイオマーカー相談（適格性評価） | ¥3,270,600 ~$20,750 per consultation | Type-specific details | PMDA | |
| Consultation for electronic study data submission method 医薬品申請電子データ提出方法相談 | ¥249,000 ~$1,580 per consultation | Type-specific details | Electronic study data (CDISC) for the NDA. | PMDA |
| Consultation on drug development pipeline 医薬品開発パイプライン面談 | ¥99,200 ~$630 per meeting | Type-specific details | PMDA selects which requests it accepts. | PMDA |
| Simple consultation on new drugs 新医薬品簡易相談 | ¥22,600 ~$140 per consultation | Type-specific details | Short questions, no data evaluation. | PMDA |
| Consultation on R&D strategy for drugs (RS strategy consultation) 医薬品戦略相談 | ¥1,541,600 ~$9,780 per consultation | Monthly intake (RS) details | Early development up to PoC, mainly for academia and ventures. A free pre-meeting is required first. | PMDA |
| RS strategy consultation for drugs, qualifying universities / ventures 医薬品戦略相談（別に定める要件を満たす大学・研究機関、ベンチャー企業） | ¥154,100 ~$980 per consultation | Monthly intake (RS) details | About 1/10 of the full fee. Venture test: SME (<=300 employees or capital <=JPY 300m); not >=1/2 owned by one company or >=2/3 by several; no profit (or profit but no business revenue) in the last fiscal year. | PMDA |
| Consultation (EN / JA) | Fee (JPY / ~USD) | Timeline | Notes | Source |
|---|---|---|---|---|
| General consultation (devices / IVDs) 全般相談 unverified* | Free per meeting | Free pre-meeting details | Free. Normally up to 30 min, up to 5 attendees. | PMDA |
| Preparatory interview of consultation for medical devices 医療機器対面助言準備面談 | ¥29,400 ~$190 per meeting | Weekly intake details | Deducted from the following formal consultation fee (which is why the '(preparatory interview completed)' prices are JPY 29,400 lower). | PMDA |
| Pre-development consultation for medical devices 医療機器開発前相談 | ¥294,100 ~$1,870 per consultation | Scheduling request details | JPY 264,700 after a preparatory interview. | PMDA |
| Consultation on the necessity of clinical trials for medical devices 医療機器臨床試験要否相談 | ¥980,300 ~$6,220 per consultation | Scheduling request details | Whether a clinical trial is needed for Japan. JPY 950,600 after a preparatory interview. | PMDA |
| Consultation on clinical evaluation report for medical devices 医療機器臨床評価報告書相談 unverified* | ¥1,960,900 ~$12,440 per consultation | Scheduling request details | Evaluation based on clinical literature etc. | PMDA |
| Consultation on protocol for medical devices (clinical trial) 医療機器プロトコル相談（治験） | ¥2,353,100 ~$14,930 per consultation | Scheduling request details | Exploratory-trial protocol: JPY 1,076,200. | PMDA |
| Evaluation consultation for medical devices (clinical trial) 医療機器評価相談（治験） | ¥1,470,700 ~$9,330 per consultation | Scheduling request details | Evaluation of trial results; JPY 2,647,200 if the protocol was not evaluated earlier. | PMDA |
| Consultation on finalization of application documents for medical devices 医療機器申請資料確定相談 | ¥390,100 ~$2,480 per consultation | Scheduling request details | PMDA | |
| Data sufficiency / application category consultation for medical devices 医療機器資料充足性・申請区分相談 | ¥134,800 ~$860 per consultation | Scheduling request details | Which approval category (new / improved / generic) applies. | PMDA |
| Prior assessment consultation for medical devices (clinical) 医療機器事前評価相談（臨床） unverified* | ¥4,498,200 ~$28,540 per consultation | Type-specific details | Other parts: quality 2,249,600; non-clinical 3,746,700; reliability 2,248,000; QMS 2,247,900 + overseas travel. | PMDA |
| Consultation before IDATEN notification for medical devices 医療機器ＩＤＡＴＥＮ届出前相談 unverified* | ¥390,100 ~$2,480 per consultation | Scheduling request details | IDATEN = Japan's approved change-plan system for devices. | PMDA |
| Simple consultation on medical devices 医療機器簡易相談 | ¥39,400 ~$250 per consultation | Type-specific details | PMDA | |
| Consultation on R&D strategy for medical devices (RS strategy consultation) 医療機器戦略相談 | ¥874,000 ~$5,550 per consultation | Monthly intake (RS) details | PMDA | |
| RS strategy consultation for devices, qualifying universities / ventures 医療機器戦略相談（別に定める要件を満たす大学・研究機関、ベンチャー企業） | ¥87,400 ~$550 per consultation | Monthly intake (RS) details | Same venture test as the drug RS row. | PMDA |
| Consultation (EN / JA) | Fee (JPY / ~USD) | Timeline | Notes | Source |
|---|---|---|---|---|
| Pre-development consultation for in vitro diagnostics 体外診断用医薬品開発前相談 unverified* | ¥196,000 ~$1,240 per consultation | Scheduling request details | PMDA | |
| Consultation for development package of companion diagnostics コンパニオン診断薬開発パッケージ相談 | ¥1,541,600 ~$9,780 per consultation | Scheduling request details | PMDA |
| Consultation (EN / JA) | Fee (JPY / ~USD) | Timeline | Notes | Source |
|---|---|---|---|---|
| SaMD comprehensive regulatory development consultation (3 sessions) プログラム医療機器 薬事開発総合対面助言（3回） unverified* | ¥4,765,000 ~$30,240 3 sessions | SaMD route details | New bundle: several consultations on one SaMD for one fee. Pilot: only universities/research institutes (under JPY 50m state funding for the seed) and ventures with 20 or fewer employees. A general consultation first is mandatory. | PMDA |
| SaMD comprehensive regulatory development consultation (5 sessions) プログラム医療機器 薬事開発総合対面助言（5回） unverified* | ¥7,147,400 ~$45,350 5 sessions | SaMD route details | Same pilot eligibility. | PMDA |
| SaMD comprehensive regulatory development consultation (10 sessions) プログラム医療機器 薬事開発総合対面助言（10回） unverified* | ¥9,879,000 ~$62,690 10 sessions | SaMD route details | Same pilot eligibility. | PMDA |
| Pre-application consultation for SaMD プログラム医療機器申請前相談 unverified* | ¥2,647,300 ~$16,800 per consultation | SaMD route details | Materials 7 weeks before the meeting if PMDA's written preliminary view is wanted. | PMDA |
| SaMD protocol consultation, two-step approval プログラム医療機器プロトコル相談（二段階承認） unverified* | ¥3,086,200 ~$19,580 2 sessions | SaMD route details | For the two-step approval route for SaMD. | PMDA |
| Consultation (EN / JA) | Fee (JPY / ~USD) | Timeline | Notes | Source |
|---|---|---|---|---|
| Pre-consultation meeting (regenerative products), no record 再生医療等製品事前面談（記録なし） unverified* | Free per meeting | Free pre-meeting details | Free; JPY 99,200 if you want PMDA to prepare a record. | PMDA |
| Procedural consultation for regenerative medical products 再生医療等製品手続相談 | ¥141,600 ~$900 per consultation | Rolling intake details | Accepted any time. | PMDA |
| Pre-development consultation for regenerative medical products 再生医療等製品開発前相談 | ¥314,700 ~$2,000 per consultation | Monthly intake details | Conceptual requirements; no data evaluation. | PMDA |
| Quality consultation for regenerative medical products 再生医療等製品品質相談 | ¥993,500 ~$6,300 per consultation | Monthly intake details | PMDA | |
| Non-clinical consultation for regenerative medical products (safety) 再生医療等製品非臨床相談（安全性） | ¥993,500 ~$6,300 per consultation | Monthly intake details | Efficacy version: JPY 944,400. | PMDA |
| Consultation before therapeutic exploratory study for regenerative medical products 再生医療等製品探索的試験開始前相談 | ¥1,153,400 ~$7,320 per consultation | Monthly intake details | PMDA | |
| Consultation after therapeutic exploratory study for regenerative medical products 再生医療等製品探索的試験終了後相談 | ¥1,687,200 ~$10,710 per consultation | Monthly intake details | PMDA | |
| Pre-application consultation for regenerative medical products 再生医療等製品申請前相談 | ¥3,684,200 ~$23,380 per consultation | Monthly intake details | PMDA | |
| Consultation on quality and safety for regenerative medical products (RS) 再生医療等製品等の品質及び安全性に係る相談 | ¥1,541,600 ~$9,780 per consultation | Monthly intake (RS) details | Before the first clinical trial notification. JPY 154,100 for qualifying universities / ventures. | PMDA |
| Consultation on R&D strategy for regenerative medical products (RS strategy) 再生医療等製品戦略相談 | ¥874,000 ~$5,550 per consultation | Monthly intake (RS) details | JPY 87,400 for qualifying universities / ventures. | PMDA |
| Simple consultation on regenerative medical products 再生医療等製品簡易相談 | ¥22,600 ~$140 per consultation | Type-specific details | PMDA |
Discounts and refunds. RS strategy consultations cost about one tenth for qualifying universities and ventures (criteria in the table). PMDA also runs a subsidy that refunds 50% of consultation and application fees for qualifying SMEs developing innovative devices, IVDs and regenerative products, and a 90% subsidy (capped) for paediatric device applications. If you withdraw a clinical-trial or RS consultation after applying and before the meeting (including rescheduling at your request), half the fee is refunded, with exceptions such as preparatory interviews and prior-assessment consultations after PMDA has sent questions. Sources: PMDA fee page, RS strategy page.
Based on PMDA's procedures (実施要綱, the implementation guideline last revised 31 July 2026) and PMDA's own performance targets. These are PMDA's stated rules and targets, not guarantees.
Application → meeting: About 2-3 months. The scheduling request is accepted once a month, in principle on the 1st working day of the month two months before the meeting month (from 10:00 on the previous working day to 12:00 on that day, since June 2026). PMDA sends the schedule within about 5 working days. Pay the fee and apply within 15 working days of the notice or by the materials date, whichever is earlier. Briefing materials are due in principle 5 weeks before the meeting (Monday 15:00). PMDA sends its written preliminary view before the meeting.
Meeting → minutes: PMDA drafts the record and confirms it with you. PMDA target: 80% of clinical-trial consultation records finalised within 30 working days after the meeting (FY2025 result: 477 of 480, 99.4%).
Application → meeting: Accepted any time (not in the monthly intake). Materials in principle 2-3 weeks before the meeting (Monday 15:00).
Meeting → minutes: For procedural consultations the record is a short summary of the key points. No numeric target is published for these.
Application → meeting: Request by e-mail (drugs: weekdays 9:30-12:00). PMDA phones back with a date; simple questions may be answered by phone only.
Meeting → minutes: No record is made (regenerative products: a record is available for a fee).
Sources: src
Application → meeting: Requests received from Wednesday noon to the next Wednesday noon are answered the following Wednesday; the interview is in principle held the week after that (about 2-3 weeks in total).
Meeting → minutes: No formal consultation record; you get a completion certificate used to discount the formal consultation.
Sources: src
Application → meeting: Submit a scheduling request with several preferred dates; PMDA replies with a meeting notice. Pay and apply within 15 working days of the notice or by the materials date. Materials 2, 3 or 5 weeks before the meeting depending on the type (5 weeks if you want PMDA's written preliminary view; 7 weeks for use-results evaluation). Intake frequency for devices is not stated on the page we checked (unverified).
Meeting → minutes: PMDA drafts the record after the meeting and confirms it with you; a meeting to finalise it may be held. No numeric target found for device clinical consultations (unverified).
Sources: src
Application → meeting: Same device procedure. For the multi-session package, a free general consultation first is mandatory; later sessions need only a request form by the agreed materials date. SaMD pre-application: materials 7 weeks before if a preliminary view is wanted.
Meeting → minutes: Record prepared after each meeting and confirmed with you.
Application → meeting: A free pre-meeting is required first. Drug / device / regenerative RS strategy consultations use the same monthly intake as drugs (1st working day of the month two months before). Quality-and-safety (regenerative) and development-plan RS consultations are accepted any time.
Meeting → minutes: PMDA target: 80% of RS strategy consultation records finalised within 30 working days after the meeting (FY2025 drugs: 60 of 60).
Application → meeting: Timetable depends on the consultation type (see the PMDA page for that type). Not summarised here.
Meeting → minutes: Not summarised here.
Sources: src
For scale. PMDA review fee plus the conformity-inspection part (GCP/GLP document checks), excluding overseas travel costs, GMP/QMS/GCTP site inspections and the separate MHLW (national) fee. These tables were last revised on 20 May 2022.
| Application | Review | Conformity | Total (JPY / ~USD) | Notes | Source |
|---|---|---|---|---|---|
| New drug, category 1 (その1), non-orphan, first application 新医薬品（その１）オーファン以外 先の申請品目 unverified* | ¥36,538,400 | ¥10,363,300 | ¥46,901,700 ~$297,620 | Plus overseas travel if inspected abroad. | PMDA |
| New drug, category 1 (その1), orphan, first application 新医薬品（その１）オーファン 先の申請品目 unverified* | ¥30,618,800 | ¥5,191,600 | ¥35,810,400 ~$227,240 | PMDA | |
| New drug, category 2 (その2), non-orphan, first application 新医薬品（その２）オーファン以外 先の申請品目 unverified* | ¥17,438,300 | ¥3,891,500 | ¥21,329,800 ~$135,350 | PMDA | |
| Generic prescription drug (with conformity inspection) 後発医療用医薬品（適合性調査あり） | ¥649,100 | ¥346,700 | ¥995,800 ~$6,320 | PMDA | |
| New medical device, Class IV, with clinical data 新医療機器（クラスⅣ）臨床あり | ¥16,431,300 | ¥1,289,900 | ¥17,721,200 ~$112,450 | Without clinical data the conformity part is JPY 89,400. | PMDA |
| New medical device, Class II/III, with clinical data 新医療機器（クラスⅡ・Ⅲ）臨床あり | ¥11,727,000 | ¥1,289,900 | ¥13,016,900 ~$82,600 | PMDA | |
| Improved medical device with clinical data, Class IV 改良医療機器・臨床あり（クラスⅣ） | ¥9,381,400 | ¥1,032,000 | ¥10,413,400 ~$66,080 | PMDA | |
| Improved medical device with clinical data, Class II/III 改良医療機器・臨床あり（クラスⅡ・Ⅲ） | ¥5,618,800 | ¥1,032,000 | ¥6,650,800 ~$42,200 | PMDA | |
| New in vitro diagnostic, companion diagnostic 体外診断用医薬品 新項目 コンパニオン診断薬 | ¥4,295,000 | – | ¥4,295,000 ~$27,250 | Non-CDx new IVD: JPY 2,534,000. | PMDA |
| New regenerative medical product 新再生医療等製品 | ¥18,803,400 | ¥1,476,200 | ¥20,279,600 ~$128,690 | PMDA |
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.
New PMDA consultation windows, fee revisions, approvals, safety notices and public comments, summarised every week with links to the originals.
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