The PMDA offers formal (fee-based) consultations to universities, research institutions, and companies that develop medical products to give guidance and advice on various issues.
In clinical trial consultations for new drugs, the PMDA not only ascertains whether a planned clinical trial complies with the requirements for regulatory submission, taking into consideration the ethical and scientific aspects of and the reliability of the clinical trial as well as the safety of trial subjects, but also gives advice that leads to an improvement in the quality of the clinical trial.
The PMDA’s formal consultations for medical devices and regenerative medical products are also provided to give guidance and advice on clinical trial protocols and data packages for regulatory submissions.
Formal consultation on R&D or regulatory submission involves consultation fee, while topics to be discussed in such consultations can be clarified free of charge in a Pre-consultation meeting.
For information on consultation fees, please refer to the “Fee for Formal Consultation” page.
Please note that fees may be changed without notice.
Furthermore, the PMDA provides universities, research institutions, and venture companies with guidance and advice on pre-proof-of-concept studies, clinical trial protocol development, and other issues. For more information, see “RS General Consultation and RS Strategy Consultation” page.
PMDA Consultation Handbook
PMDA Consultation Handbook provides guidance on how to use PMDA consultation services, when seeking marketing authorization for pharmaceuticals, including vaccines, in Japan.
The handbook also includes practical information for overseas developers, including considerations on “Interpretation” and “Importance of Identifying a Development Partner in Japan”.
For details on PMDA consultation services, please refer to the handbook.
PMDA Consultation Handbook（Japanese Original Version 1.1）[5.8MB]／PMDA Consultation Handbook（English Version 1.2）[6.4MB]
Contact point for inquiries from overseas developers
For initial inquiries from overseas developers interested in product development in Japan, please contact us at the following e-mail address:
rs-contact[at]pmda.go.jp
- Please replace [at] with @ when you send an e-mail.
- It will normally take about 10 working days to answer.
Before sending your inquiry, please read the following points carefully.
- Please check our Frequently Asked Questions (FAQ) if your current inquiry is already described.
- Please check the following information pages.
- PMDA does not control the followings. Please refer to the Contact List[50.1KB] and contact the respective authorities or organizations on these matters directly.
- - the pricing and reimbursement of medical products
- - patents on medical products
- - food products including supplements
- - cosmetics
- - Japanese Pharmaceutical Excipients (JPE) and Japanese Pharmaceutical Codex (JPC)
- - medical products for animal use
- - distribution and import of medical products
- - marketing license for medical products
- - license for wholesale distribution
- Channel for whistleblowing: In order to protect whistleblowers in the public interest, the government has established an official reporting channel for whistleblowing in accordance with the Whistleblower Protection Act. If you are considering making a report concerning an act in violation of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, etc. (including Japanese ministerial ordnances such as GCP and GMP/QMS) within the enterprise, please report to the official reporting channel for whistleblowing of the Ministry of Health, Labour and Welfare(available only in Japanese), which has jurisdiction over the act and ordinances.
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