PMDA review time · approval batches · NHI listing
PMDA's official review-time targets and what it actually achieved, the standard review stages, and the days we measure between the MHLW committee, the approval letter and the NHI price listing, from every approval since April 2024.
Updated 2026-10-30 · 369 approvals in 25 batches · official figures to FY2025 (Sep)
Short answer. PMDA’s target is 12 months from filing to approval for a standard new-drug application and 9 months for priority review, each measured at the 80th percentile, and it is meeting them: in FY2024 the 80th-percentile total review time was 12.0 months for standard products (95 approvals) and 8.9 months for priority products (40 approvals); the one SAKIGAKE product took 4.8 months (PMDA FY2024 results, Dec 2025 update). The median for new active ingredients approved in calendar 2024 was 10.0 months (n=63), against 9.9 in the US and 14.0 in the EU (JPMA OPIR). After the review, our own data show a median 22 days from the MHLW committee meeting to the approval letter and 55 days from approval to the NHI price listing.
| Category | Target (total review time) | FY2024 achieved | FY2024 approvals | FY2025 to end-Sep | FY2025 approvals (to Sep) |
|---|---|---|---|---|---|
| New drugs, priority review (優先品目) | 9 months at the 80th percentile | 8.9 months | 40 (38 met) | 8.9 months | 24 |
| New drugs, standard review (通常品目) | 12 months at the 80th percentile | 12.0 months | 95 (84 met) | 11.6 months | 51 |
| New drugs, SAKIGAKE / pioneering designation | 6 months | 4.8 months (one product) | 1 (1 met) | — | — |
Total review time = filing to approval, including the time the applicant takes to answer inquiries. Applications filed on or after the 16th of a busy month are counted from the 1st of the next month, and administrative delay between the committee month and approval beyond two months is capped at two months (plan wording). Sources: PMDA, 令和6事業年度業務実績【概要】 p.7 and 令和7年度のこれまでの事業実績及び今後の取組について (Dec 2025) p.3; plan overview MHLW. Translated by us.
| Category | Target | FY2024 achieved | FY2025 to end-Sep |
|---|---|---|---|
| New medical devices, priority | 10 months (median) | 8.5 months | 8.9 months |
| New medical devices, standard | 14 months at the 80th percentile | 11.7 months | 12.0 months |
| Improved devices with clinical data | 10 months at the 60th percentile | 9.0 months | 9.0 months |
| Improved devices without clinical data | 6 months at the 60th percentile | 6.0 months | 5.8 months |
| Generic (me-too) devices | 4 months at the 60th percentile | 3.8 months | 3.6 months |
Device targets exclude applications where the applicant needed longer than the target to complete its dossier. Source: PMDA Dec 2025 update, pp.27–28 (same PDF). New device approvals themselves: device approvals page.
MHLW published the standard stage lengths that add up to the 12-month target (ranges are the total time allowed for PMDA and the applicant at each stage, based on past performance; applicable when no particular concern arises).
| Stage | Time |
|---|---|
| Filing → initial meeting (incl. GLP/GCP and data-integrity assessment) | 1.9–2.5 months |
| Initial meeting → inquiries on important issues | 0.2–0.7 months |
| Inquiries → expert discussion | 4.7–8.3 months |
| Expert discussion → review report completed | 1.2–1.9 months |
| Review report → MHLW committee → approval | 0.7–1.9 months |
Source: MHLW Evaluation and Licensing Division, Administrative Notice of 30 March 2012, “On the Standard Review Timeline for New Drug Applications” (PMDA provisional English translation, PDF). GMP inspection runs in parallel with the review.
MHLW approves new drugs in batches a few times per quarter. The table lists every batch in our data (369 approvals; FY2024 10 batches, FY2025 10 batches, FY2026 5 batches), with how many were new active ingredients and how many carried priority, orphan, SAKIGAKE or conditional flags on PMDA’s list.
| Approval date | Approvals | New active ingredients | Priority | Orphan | SAKIGAKE | Conditional | |
|---|---|---|---|---|---|---|---|
| 2026-09-16 | 32 | 12 | 12 | 11 | — | 2 | |
| 2026-08-24 | 23 | 5 | 11 | 11 | 2 | — | |
| 2026-06-19 | 29 | 8 | 12 | 12 | — | — | |
| 2026-05-18 | 9 | 2 | 2 | 2 | — | — | |
| 2026-05-11 | 1 | 1 | 0 | 0 | — | — | |
| 2026-03-23 | 20 | 4 | 5 | 5 | — | 1 | |
| 2026-03-06 | 1 | 1 | 1 | 1 | — | — | |
| 2026-02-19 | 15 | 3 | 3 | 3 | — | — | |
| 2025-12-22 | 22 | 12 | 9 | 9 | — | — | |
| 2025-11-20 | 7 | 0 | 3 | 3 | — | — | |
| 2025-09-19 | 33 | 12 | 8 | 8 | — | 1 | |
| 2025-08-25 | 12 | 3 | 4 | 4 | — | — | |
| 2025-08-08 | 1 | 1 | 0 | 0 | — | — | |
| 2025-06-24 | 19 | 6 | 9 | 9 | — | — | |
| 2025-05-19 | 10 | 2 | 3 | 3 | — | — | |
| 2025-03-27 | 22 | 7 | 7 | 7 | — | — | |
| 2025-02-20 | 7 | 1 | 0 | 0 | — | — | |
| 2024-12-27 | 25 | 15 | 6 | 6 | — | — | |
| 2024-11-22 | 8 | 0 | 1 | 1 | — | — | |
| 2024-09-24 | 32 | 14 | 15 | 12 | — | — | |
| 2024-09-13 | 1 | 0 | 0 | 0 | — | — | |
| 2024-09-05 | 1 | 0 | 0 | 0 | — | — | |
| 2024-08-28 | 8 | 0 | 1 | 1 | — | — | |
| 2024-06-24 | 25 | 11 | 4 | 3 | 1 | — | |
| 2024-05-17 | 6 | 0 | 0 | 0 | — | — |
Across all 369 approvals: standard review 253, priority 116, orphan 111, public-knowledge-based 22, SAKIGAKE 3, conditional 4. Flags as printed on PMDA’s approval lists.
Japan’s review clock is among the fastest, but a drug reaches Japan late when its Japanese filing comes late. PMDA estimates the median drug lag for new active ingredients filed in Japan in FY2024 at 2.0 years, of which the review lag is 0 years and the development lag (gap between the US filing and the Japanese filing) is 2.0 years (PMDA, Dec 2025, p.12). On this site, the median wait between first FDA approval and Japanese approval for new active ingredients approved in FY2024–FY2026 is 876 days (n=97); versus EMA 647 days (n=82). Drugs that have not been filed in Japan at all are on the drug-loss list.
The target is 12 months from filing for a standard application and 9 months for priority review, at the 80th percentile. FY2024 results were 12.0 and 8.9 months. The 2024 median for new active ingredients was 10.0 months (JPMA OPIR).
Orphan drugs and drugs for serious diseases with high medical need are designated for priority review (優先審査); the review target drops from 12 to 9 months. In our data 116 of 369 approvals since April 2024 carried the priority flag, most of them orphan drugs.
Within 60 days as a rule and 90 days at the latest. Our observed median is 55 days; 66% of listings were within 60 days and 89% within 90.
Not as a rule. MHLW’s notice of 25 December 2023 states that a phase 1 study in Japanese subjects before a multi-regional trial is in principle not required when the available data can explain the safety and tolerability of the planned dose in Japanese participants, and that for drugs with high unmet need (rare, serious or pediatric diseases) Japan may join the global trial without a Japanese phase 1 study given appropriate informed consent (医薬薬審発1225第2号, PDF). Whether it applies is product-specific; the consultation route is the way to settle it with PMDA (PMDA consultations).
Content under the Public Data License 1.0 (PDL1.0) is used under PDL1.0 (compatible with CC BY 4.0). Figures quoted from PMDA documents are our unofficial translation; the Japanese originals prevail. “Our data” figures are computed from public MHLW / PMDA documents and can be wrong where names failed to match. This site is independent and not affiliated with PMDA, MHLW or JPMA. Not regulatory advice.
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