PMDA Review Process and Timelines
Step-by-step review workflowβ
1. Application receipt. PMDA acknowledges receipt and assigns a review team. The clock starts on the date of formal acceptance (not submission β PMDA may return incomplete applications).
2. Initial completeness check. PMDA checks that all required modules are present. Incomplete applications are returned or put on hold.
3. Scientific review. PMDA's review team (including clinicians, scientists, and engineers with relevant expertise) conducts a detailed review of each module. Most reviews involve a Question and Answer (Q&A) process.
4. Q&A rounds. PMDA issues a list of questions (η §δΌδΊι β shΕkai jikΕ) to the MAH. The MAH must respond in writing. Multiple Q&A rounds are normal for complex applications. Each round pauses the review clock.
5. QMS inspection. For most Shonin applications, PMDA conducts a QMS inspection of the manufacturing site(s). This can be on-site (domestic or foreign) or document-based. The inspection is coordinated with the review timeline.
6. Review report. PMDA prepares a draft review report and may share it with the MAH for factual correction. PMDA then finalises the report and submits it to MHLW.
7. MHLW decision. MHLW's Pharmaceutical Affairs and Food Sanitation Council (θ¬δΊγ»ι£εθ‘ηε―©θ°δΌ) reviews the PMDA report and makes the formal approval recommendation. MHLW then issues the Shonin.
Standard review timelinesβ
PMDA publishes target review timelines (similar to FDA MDUFA goals):
| Device type | Total target (calendar months) | PMDA review time target |
|---|---|---|
| Standard new device | 17 months | 12 months |
| Priority review device | 9 months | 6 months |
| In vitro diagnostics (standard) | 12 months | 9 months |
"Total target" includes both PMDA review time and MAH response time to Q&As. In practice, total elapsed time for standard Shonin applications is commonly 18β24+ months for complex Class III/IV devices.
The Q&A processβ
Q&As are the main mechanism PMDA uses to seek clarification or additional data. Best practices:
- Respond promptly β delayed responses extend total elapsed time
- Be comprehensive β incomplete answers lead to follow-up questions
- Agree with PMDA before conducting new studies in response to a Q β additional studies must be pre-aligned with PMDA's expectations
- Maintain a tracking log of all questions and responses
PMDA's review fee structureβ
PMDA charges review fees set by Cabinet Order. Fees vary by device class, novelty, and whether clinical data review is required. The fee structure is published by PMDA and should be confirmed for each specific application type.