PMDA Consultation Guide for Foreign Companies
The Pharmaceuticals and Medical Devices Agency (PMDA) offers consultation schemes matched to each phase of development. This guide explains how the system works, why startups and academia should begin with Regulatory Science (RS) Consultation, and how to handle the points that matter most for foreign companies — the Japanese language and the way consultations are arranged.
⚠️ Before you start
PMDA’s procedures, communications, and forms are handled in Japanese. This guide assumes you will work with a Japanese partner — a Marketing Authorization Holder (MAH) or Designated MAH (DMAH) — and reads best with that in mind. PMDA’s English webpages are partly machine-translated and attached files are often Japanese-only, so treat the Japanese original as authoritative.
Contents
- PMDA’s consultation schemes at a glance — and where to start
- Why we recommend RS Consultation — a fit for startups, ventures & academia
- The reality for foreign companies — consultations run in Japanese; secure an MAH/DMAH first
- How to consult PMDA effectively — your approach
- Reference materials
- Related JPRO Pages
1. PMDA’s consultation schemes at a glance — and where to start
PMDA provides a range of consultation windows matched to each phase of development. The full menu, with the official categories, is set out on PMDA’s English consultations page. Source: Consultations (PMDA)
If you are a startup, venture, or academic developer, however, you do not need to master the whole menu — we recommend making use of RS Consultation (explained in the next section).
Note -- PMDA handles matters related to regulatory approval; the pricing and reimbursement of medical products are handled by the Ministry of Health, Labour and Welfare (MHLW). Source: Consultations (PMDA) For how reimbursement works in Japan, see our Medical Device & IVD Reimbursement page.
2. Why we recommend RS Consultation — a fit for startups, ventures & academia
What RS Consultation is
PMDA’s RS Consultation provides guidance and advice — mainly for universities, research institutes, and venture companies — on the studies and clinical-trial plans needed to develop a drug, medical device, IVD, or regenerative medical product. In practice, it is essential to align with PMDA in advance at each key step, rather than proceeding on your own assumptions. Source: RS General Consultation and RS Strategy Consultation (PMDA)
Three benefits of RS Consultation
- Approachable. It is designed for those without in-house regulatory experts, such as universities and startups, so it is easy to approach.
- De-risk development. By consulting before your plan is fixed, you can confirm whether your approach is acceptable before you act, reducing the risk of costly rework later.
- Economic incentive. When you qualify, consultation fees are substantially reduced (see “Fees and the venture / academia reduction” below).
The three steps of RS Consultation
- RS General Consultation — free. PMDA confirms whether your intended consultation is appropriate and gives general explanations of the guidelines, notices, and systems relevant to an approval application. No meeting minutes are prepared. Source: RS General Consultation (PMDA)
- Pre-consultation meeting (RS Strategy Consultation) — free. About 30 minutes, up to ~5 attendees. Organizes the points and scope of discussion and checks your materials. No meeting minutes are prepared. Source: Pre-consultation meeting (PMDA)
- RS Strategy Consultation (face-to-face advice) — paid. The review team examines your submitted materials and gives PMDA’s official view. An official consultation record is prepared and issued afterward. Source: RS Strategy Consultation (PMDA)
Fees and the venture / academia reduction
Face-to-face advice carries a fee, but applicants meeting the requirements for universities, research institutes, and venture companies receive a large reduction (the reduced fee is one-tenth of the standard — about a 90% cut). We do not reproduce the figures here, because PMDA revises them periodically; please check the official fee page for the current amounts. Source: Fees page (PMDA, Japanese)
Eligibility, in outline:
- Venture companies — a small or medium-sized enterprise (300 or fewer employees, or capital of ¥300 million or less), not majority-owned by another single corporation, and meeting the other stated conditions.
- Universities / research institutes — not having received public research funding above a set threshold for the seed concerned, among other conditions.
Note for foreign companies. The reduction is built around Japan’s SME criteria, and the supporting documents required assume a Japanese corporate entity. As a first step, consult PMDA — including on whether your company meets the reduced-fee requirements — via the contact details on PMDA’s official page. Source: Comprehensive Guide to RS Consultation (PMDA)
TIPS
When entering the Japanese market, foreign companies normally work through an MAH/DMAH, who handle the regulatory procedures — including PMDA consultations — on their behalf. As a result, you can usually proceed without separately hiring a regulatory consultant. Make securing an MAH/DMAH your first priority. Even before you have one, you can get a rough idea yourself of whether your product is a medical device in Japan (see How to determine if a product is a medical device), and which Japanese Medical Device Nomenclature (JMDN) it may fall under (see how to confirm JMDN).
3. The reality for foreign companies — consultations run in Japanese; secure an MAH/DMAH first
This is the section that matters most for foreign companies.
Consultations are conducted in Japanese
PMDA states it plainly: because the required procedures, communications, and forms are, as a rule, processed in Japanese, it strongly recommends appointing a Japanese Marketing Authorization Holder (MAH) if you are considering entering the Japanese market, and the consultation should be requested through that MAH. Source: Consultations (PMDA)
The practical consequence: secure your MAH or DMAH first, and consult PMDA through them. For what a DMAH does, see our Designated Marketing Authorization Holder (DMAH) Summary page.
If you want to make inquiries in English
For inquiries in English, the following windows may help:
- RS inquiry window (English). For RS General and RS Strategy Consultation, PMDA accepts inquiries in English; the contact address and response time are given on PMDA’s official page. Source: Consultations (PMDA)
- PMDA Washington, D.C. Office (for U.S.-based developers). Opened November 1, 2024; provides early, general development consultation and related services in English. Product-specific requirements continue to be handled through PMDA’s main (Japanese) consultations. Source: PMDA Washington, D.C. Office
Note that these are windows for inquiries in English; they do not let you run the whole consultation process in English. PMDA consultations are, as a rule, conducted in Japanese.
4. How to consult PMDA effectively — your approach
Come well prepared to a PMDA consultation. The following five points reflect how the system actually works.
- Bring a hypothesis and its evidence. A consultation is where PMDA judges whether your plan is acceptable — not where they design it for you. Bring a concrete plan backed by reasonable data and rationale.
- Frame each issue as a set. For every question, present the background, the data, your proposal, and the specific question. Vague questions get vague answers.
- Build a self-contained, high-quality document package. The quality of your materials largely determines the quality of the advice. Prepare them as recommended at the pre-consultation meeting.
- Treat the official record as an asset. Face-to-face advice ends in an official PMDA record. Shape the discussion with that downstream document — useful for approval, fundraising, and partnering — in mind.
- Lead the discussion. You drive the meeting. Bring the hypothesis, the rationale, and the proposed path, and use PMDA to confirm and refine it.
References: RS General Consultation and RS Strategy Consultation (PMDA) / RS Strategy Consultation pamphlet (PMDA)
TIPS
A PMDA consultation is not “consultation” in the everyday sense — it is where you confirm whether your own plan is acceptable. As a rule, align with PMDA in advance on every key point before you proceed. The effective posture is: “We have planned it this way, and we think it is reasonable. Is this acceptable to you?”
5. Reference materials
English (PMDA)
- Consultations (overview & contact), PMDA (English)
- RS General Consultation and RS Strategy Consultation, PMDA (English)
- Comprehensive Guide, “RS general·RS strategy consultation” (May 2024 ver.1.0), PMDA (English)
Japanese (PMDA) / Law
- Consultation services — top page (相談業務), PMDA (Japanese)
- List of face-to-face advice / pre-consultation, etc. (対面助言・事前面談一覧), PMDA (Japanese)
- RS Strategy Consultation — face-to-face advice (対面助言（RS戦略相談）), PMDA (Japanese)
- Fees (手数料一覧), PMDA (Japanese)
- Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act; 薬機法), Japanese/English bilingual, Japanese Law Translation (Japanese / English) — convenient for locating provisions, but the English translation may not reflect the latest amendments; for the current authoritative text, refer to the Japanese original (e-Gov).