This “Contact Us E-mail form” is established for the purpose of receiving inquiries from overseas regarding PMDA's jurisdiction. If you wish to contact us for inquiries, please send email by using the following form.
It will normally take about 15 working days to answer.
(Note) Please refrain from sending sales-related emails from this form. We will not be able to reply to any inquiries for such purpose.
Before sending your inquiry, please read following points carefully.
- Please check our Frequently Asked Questions (FAQ) if your current inquiry is already described.
- Please check the following information pages.
- Requirements for individual products will be assessed and answered on a case-by-case basis in PMDA's fee-based consultation services. You can find more information on the PMDA’s Consultation Services on “Consultations” page.
- PMDA does not control the followings. Please refer to the Contact List [50.19KB] 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.
E-mail Form
For Industry in U.S. - for development in Japan
- PMDA Washington D.C. Office provides U.S. companies and related parties with general consultation services, and assists them in understanding Japanese regulatory process and procedures on reviews and post-marketing safety measures by both in person and online.
