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

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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

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References

Footnotes

1. PMDA, “Consultations” (English), Pharmaceuticals and Medical Devices Agency. https://www.pmda.go.jp/english/review-services/consultations/0002.html ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹ ↩¹² ↩¹³ ↩¹⁴ ↩¹⁵ ↩¹⁶ ↩¹⁷ ↩¹⁸ ↩¹⁹ ↩²⁰ ↩²¹ ↩²²