Scope of Consultation
PMDA Washington D.C. Office is now offering general consultation services to assist companies and related parties understand Japanese regulatory process and procedures on reviews and post-marketing safety measures. Our services encompass providing:
- Information on regulations or procedures under the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Act No. 145 of August 10, 1960) of Japan
- A general explanation of basic matters for practical regulatory application of new seeds for drugs, medical devices, and regenerative medicine products
- An explanation of PMDA's services, and support in selecting one or more consultation categories provided by PMDA's review team in Japan
Please note that PMDA Washington D.C. Office will not provide any advices specifically related to business, strategic or legal matters on your products. However, upon request, PMDA’s review team in the Tokyo Headquarters, through separate consultation arrangements, will provide guidance and advice on specific development plans for individual products (e.g., sufficiency of non-clinical study data, appropriateness of clinical study protocols)1).
1) https://www.pmda.go.jp/english/review-services/consultations/0002.html
Who can request for a general consultation
Companies and related parties engaging in development of drugs, medical devices or regenerative medicine products in U.S. and interested in obtaining regulatory approvals for those products in Japan may request for our general consultation.
How we provide a general consultation
To request for our general consultation services, please fill out the “Application Form for General Consultation” and submit to the following e-mail address.
At the time of submission of the Form, you may submit materials necessary for the purpose of the consultation with a list of attached materials.
Application form for General Consultation [89.4KB]
E-mail:
Consultation[at]dc-office.pmda.go.jp
(Note) To block unsolicited emails being sent to us, we request you to replace [at] with @ , when you send an email. Thank you for your understanding.
- In general, a consultation will be provided at PMDA Washington D.C. office. If an applicant prefers an online meeting, we are amenable to such an online consultation using Microsoft Teams, hosted by the applicant at your sole responsibility. Please write so on the application form if you wish to have a general consultation online.
- Please enter at least a couple of preferred dates and times for a general consultation on the application form. After receiving the application, we will contact you to schedule a general consultation by e-mail. Please note that we may not be able to accommodate your preferred dates and times, in which case we will propose an alternative date and time for the consultation.
- A consultation will be normally for 30 minutes or less per application.
- Due to the size of our meeting room, your participants are limited to 2 to 3 per session. If you have more attendees, please consult with us in advance.
- We may contact you with inquiries about the contents of the consultation before the scheduled date for the meeting. Depending on the content of the consultation, we may provide our responses by telephone.
- Consultations will be available between 10:00 a.m. and 5:00 p.m. EST, Monday through Friday.
- A general consultation is free of charge.
- A general consultation is conducted orally. No additional information or documents will be provided outside the consultation.
Disclaimer
PMDA will not disclose any information obtained during the General Consultation without your consent except for cases in which PMDA is required to disclose such information, even if provided by the applicant on a confidential basis, under applicable laws including, but not limited to, the Act on Access to Information Held by Incorporated Administrative Agencies (Act No. 140 of December 5, 2001) of Japan. You agree that PMDA shall have no liability for any damages, direct or indirect, resulting from its compliance with any such applicable disclosure laws.