Priority Review Timelines: PMDA Targets versus 80th Percentile Performance

1. Key takeaways

The processing-period targets PMDA publishes externally are institution-set efficiency targets: 14 months for new medical devices and 10 months for priority review. Actual results are disclosed year by year at the 80th percentile, standing at 11.4 months for standard review and 8.7 months for priority review in FY2023. GRZAN recommends scheduling projects at the upper edge of the performance range and explicitly excluding applicant response time from the review clock.

• Article 23-2-5 of the PMD Act carries the priority review and publication provisions; the paragraph numbering was rearranged by Act No. 37 of 2025, so confirm the current text on e-Gov before citation.
• Act No. 37 of 2025, promulgated on 21 May 2025, added the duty to publicize when approval is granted after priority review.
• Standard review results at the 80th percentile: FY2019 11.1, FY2020 10.8, FY2021 11.9, FY2022 12.0, FY2023 11.4 months.
• Priority review results at the 80th percentile: FY2019 7.3, FY2020 8.4, FY2021 8.9, FY2022 8.8, FY2023 8.7 months.
• GRZAN’s assessment: the statistics exclude clock-stopped applicant time, so corporate reply efficiency never appears in the public data and must be measured internally.
• The publication duty added in 2025 turns each priority review approval into a verifiable reference point, which companies can use to benchmark their own scheduling against comparable items rather than relying on anecdote.

2. Legal basis

Priority review and publication. Article 23-2-5 of the PMD Act contains the provisions on priority review and publication. The paragraph numbering was rearranged by the amendment in Act No. 37 of 2025; when citing, confirm the specific paragraph against the current e-Gov text.

The 2025 amendment. Act No. 37 of 2025, promulgated on 21 May 2025, added to Article 23-2-5 the provision that the Minister of Health, Labour and Welfare publicizes when approval is granted after priority review or investigation. This gives the application and outcome of priority review external traceability.

Targets. PMDA’s Profile of Services states the review processing-period targets: 14 months for new medical devices and 10 months for priority review.

Performance. PMDA’s disclosed results at the 80th percentile show standard review at 11.1 months in FY2019, 10.8 in FY2020, 11.9 in FY2021, 12.0 in FY2022 and 11.4 in FY2023; priority review at 7.3 months in FY2019, 8.4 in FY2020, 8.9 in FY2021, 8.8 in FY2022 and 8.7 in FY2023.

Current legal corpus. Act No. 145 of 1960 (the PMD Act).

Practical estimate: schedule standard review at a 12-month magnitude and priority review at a 9-month magnitude, with applicant response time listed separately.

3. Expert insights

The target sits below several years of actual results, so it is a direction, not a guarantee. The FY2021 and FY2022 standard-review results, 11.9 and 12.0 months, both exceed the FY2020 figure of 10.8 months, and the five-year range runs from 10.8 to 12.0 months. Treating the 14-month target as an upper bound for scheduling is safe in most years; treating the 10-month priority target as a commitment is dangerous. GRZAN phrases it for clients this way: the target is what the institution aims for, the percentile series is what actually happens, and plans should be built on the latter.

The statistics exclude applications whose clock-stopped time exceeded the target. PMDA states explicitly that the statistical object for processing periods excludes clock-stopping time consumed by applicants preparing submission materials beyond the target period. The practical consequence is that corporate response efficiency never appears in the published data. A company that answers inquiries slowly will not see that slowness in the official numbers, yet will feel it in its launch dates. Internal measurement of the clock-stopped periods is therefore mandatory for anyone scheduling a Japanese submission. The ledger also serves the negotiation side of the relationship: when an inquiry response is genuinely complex, documented evidence of past reply discipline strengthens the case for the extensions the procedure allows.

The 2025 publication duty improves traceability. Act No. 37 of 2025 requires the Minister to publicize when approval is granted after priority review. This makes the application and the outcome of priority review externally checkable, and companies can use the published record to trace the actual processing rhythm of comparable items. For project planning, the publication record functions as a free sample set of how the mechanism behaves for devices resembling the one being scheduled. Combined with the five-year percentile series, it gives a scheduling basis that is publicly verifiable end to end, from eligibility through outcome, without depending on informal benchmarking.

4. Practical recommendations

• Schedule at the upper edge of the results: reserve around 12 months for standard review and around 9 months for priority review, with applicant response time itemized separately.
• Keep a clock-stop ledger recording the start and end dates of every inquiry and answer, quantifying the time consumed on the corporate side.
• Confirm priority review eligibility before submission, through consultation or the scheme requirements; do not assert it after the fact.
• Use the publication record to trace comparable items under priority review, as a reference sample for this project’s schedule.
• Keep the distinction between the processing-period target and the 80th-percentile results explicit in all internal and external planning documents.

5. Verification checklist

• □ Is the project schedule built on the upper edge of PMDA’s results range, not only on the target value?
• □ Is a clock-stop ledger in place, quantifying applicant response time?
• □ Was priority review eligibility confirmed before submission?
• □ Are the processing-period target and the 80th-percentile results kept as distinct concepts in the plan?
• □ When citing Article 23-2-5, has the paragraph number been checked against the current e-Gov text?

Regulatory information verified as at 29 October 2026. Legal texts follow the current provisions published on e-Gov and the notices issued by MHLW and PMDA, and must be rechecked after amendment or repeal. Time limits and procedural details reflect the official position on that date; content marked practical estimate has no legal effect.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, in-country representative and local testing support for the Japanese market. Our team manages PMDA premarket submissions and notification procedures, coordinates clinical evidence, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com