ElendiLabs
AEMPS 的國家登記與 EU 的 MDR/IVDR 在功能上互補：EUDAMED 提供跨境一致的資料庫，而 AEMPS 的國家登記可覆蓋過渡期或特定國家義務。企業應該：1) 檢查是否在過渡期內需要國家登記；2) 準備技術檔案、標籤與合規聲明（西班牙語）；3) 與授權代表溝通以確保資料一致。
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December 24, 2025
Approximately 5 minutes
PMDA consultations in Japan: what they are and how to use them
PMDA’s consultation program is designed to provide guidance and advice on clinical trials and on the data needed for regulatory submissions for drugs, medical devices, and cellular/tissue-based products.1 Used well, consultations can reduce late-stage surprises by aligning development plans with what reviewers will need to judge quality, efficacy, and safety.
What PMDA consultations cover
PMDA describes consultations as a service to advise on:
- Clinical trials for drugs, medical devices, and cellular/tissue-based products.1
- Data for regulatory submissions, including how to build a dossier that meets expectations.1
For clinical trial consultations for new drugs, PMDA states it checks whether a proposed trial complies with requirements for regulatory submission, considering ethical and scientific aspects, reliability of the trial, and safety of trial subjects, and provides advice to improve the trial.1
Key consultation formats and when to use them
1) Consultation meetings (paid) vs pre-consultation meetings (free)
PMDA explains that a consultation meeting on R&D or regulatory submission involves a consultation fee, while topics to be discussed may be clarified free of charge in a Pre-consultation meeting.1 Practically:
- Use pre-consultation to confirm the right category, scope, and readiness.
- Use a paid consultation when you need formal feedback on plans, protocols, or evidence expectations.
2) Prior assessment consultations (pre-submission)
PMDA notes that, starting in FY2009, it provides prior assessment consultations where reviewers evaluate data on quality, efficacy, and safety in the pre-submission stage, and that the consultation process becomes part of the review once an application is submitted.1
This format can be valuable when you have substantial datasets and want earlier alignment on how reviewers will interpret them.
3) RS General Consultation and RS Strategy Consultation (for early “seed-stage” innovation)
PMDA positions Regulatory Science (RS) General Consultation and RS Strategy Consultation as consultation types launched to help realize innovative drugs, medical devices, and regenerative medical products—especially for universities, research institutions, and venture companies with promising seed-stage research or technologies.1
PMDA states that these RS consultations provide advice on tests needed in early development and necessary clinical trials, covering scope from late candidate selection through the initial stage of clinical development (POC studies / Phase IIa).1
PMDA also publishes an RS consultation pamphlet and lists dedicated contact information for RS consultations.1
Practical access considerations for overseas teams
Japanese-language operations and the role of a Japanese MAH
PMDA cautions that required procedures, communication, and forms are processed in Japanese, and it strongly recommends appointing a Japanese Marketing Authorization Holder (MAH) if you are considering entering the Japanese market. It further states that consultation meetings should be requested and arranged through the intermediary of such an MAH.1
PMDA adds that if you request only the free Pre-consultation meeting, it may be acceptable to accompany an interpreter instead of appointing a Japanese MAH.1
Fees
PMDA indicates that consultation fees and other user fees are available from a separate fees page (noting it is available only in Japanese), and that fees may be changed without notice.1
RS consultation contact
For RS General/Strategy consultations, PMDA provides a contact email and notes to replace “[at]” with “@”.1
How to prepare for a productive PMDA consultation
A practical way to approach PMDA consultations is to be explicit about:
- Your intended product category (drug, device, regenerative/cellular/tissue-based).
- Development stage (seed-stage, preclinical, early clinical, pre-submission).
- Key decision questions you want PMDA to address (e.g., adequacy of endpoints, trial design, validation evidence, nonclinical package strategy).
- Evidence map: what data exists today, what is planned, and what remains uncertain.
Because PMDA states it considers ethics, scientific validity, reliability, and subject safety in trial consultations for new drugs, prepare concise rationales and risk controls that directly address those dimensions.1
Q&A
Q1: What is a PMDA consultation, in plain terms?
It is a structured opportunity to receive PMDA guidance on clinical trials and/or the data needed for regulatory submissions for drugs, medical devices, and cellular/tissue-based products.1
Q2: Are there free consultation options?
Yes. PMDA states that topics may be clarified free of charge in a Pre-consultation meeting, while consultation meetings on R&D or regulatory submission involve a fee.1
Q3: When should we consider a prior assessment consultation?
When you have meaningful quality/efficacy/safety data and want reviewer input before submission—PMDA notes this is a pre-submission evaluation and later becomes part of the review after application.1
Q4: We are a startup/university team with early technology. Which consultation is most relevant?
PMDA highlights RS General Consultation and RS Strategy Consultation as designed mainly for universities, research institutions, and venture companies with seed-stage technologies, covering late candidate selection through Phase IIa/POC.1
Q5: Do we need a Japanese Marketing Authorization Holder (MAH) to request consultations?
PMDA strongly recommends appointing a Japanese MAH for market entry and states consultation meetings should be requested and arranged via the intermediary of the MAH.1 For only the free pre-consultation, PMDA notes an interpreter may be acceptable instead of an appointed MAH.1
Q6: Where do we find fee information?
PMDA points to a separate “Fees for reviews and face-to-face consultations, etc.” page (Japanese only) and notes fees may change without notice.1
Q7: How do we contact PMDA for RS consultations?
PMDA provides an email contact for RS General/Strategy consultations: rs-contact[at]pmda.go.jp (replace [at] with @).1
References
Footnotes
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Questions & Answers (6)
M
María
Guest
Hello — we plan to market custom dental implants in Spain and want to know if registration in the AEMPS national register is required for custom-made implants, and whether additional vigilance linkage to EUDAMED is needed.
ElendiLabs
Custom-made devices still fall under national oversight. In Spain certain custom devices must be recorded with AEMPS to ensure traceability and post-market surveillance; linkage to EUDAMED may be required where EUDAMED functions apply. Check national guidance on custom-made device reporting and prepare device description and MAH/authorized representative details.
陳
陳曉
Guest
想請問如果產品已在EUDAMED登記，但有西班牙國內特別要求（例如本地製造商登記或公費採購資料），是否還需在 AEMPS 的國家資料庫額外登記？ — 陳曉
ElendiLabs
即便已在 EUDAMED 登記，若西班牙對特定類別的產品要求國家級的補充資料（例如本地製造商或補充臨床資訊），仍可能需要在 AEMPS 登記。建議先做 pre-check 並準備好西班牙語文件以便加速審查。
M
Miguel
Guest
我們是一家外國公司，想了解在AEMPS進行上市前登記時是否需要西班牙本地代表（authorized rep）或可以由歐盟授權代表處理？
ElendiLabs
Foreign manufacturers usually need an EU Authorized Representative for regulatory interactions, but for certain national processes AEMPS may require a local contact or representative. In practice engage an EU/Spain-based authorized representative to handle registrations and correspondence with AEMPS.
A
Anonymous
Guest
我們想在西班牙註冊一款IVD試劑盒，該試劑在歐盟過渡期間有哪些國家層面的登記或臨時要求需要注意？
ElendiLabs
在IVDR/MDR過渡期，西班牙的國家登記主要用於尚未完全過渡或有國家特殊義務的產品。注意檔案要能夠支持市場監管（traceability）與不良事件回報。建議檢查 AEMPS 官方“Registros nacionales”頁面，並保留完整的技術文件與標籤翻譯。
A
Anonymous
Guest
Do AEMPS national registers apply to Class I medical devices that are not subject to notified body oversight? If so, what data fields are typically required at registration?
ElendiLabs
Yes — some national registers capture Class I devices that are not covered by notified body certificates for traceability. Typical required fields include device name, classification, intended purpose, manufacturer/authorized representative details, and UDI/lot information where applicable.
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Sofia
西班牙AEMPS的national register與歐盟IVDR/MDR怎麼銜接？若產品尚未完成過渡，企業應該先做什麼準備？