Please apply for a Pre-consultation meeting first.
Apply for RS strategy consultation after the Pre-consultation meeting.
Pre-consultation meeting is conducted for efficient RS Strategy consultation to organize the content (scope) and points of discussion in the Consultation, and to confirm the content of materials.
In addition to technical experts from Division of Innovation Support and Pharmaceuticals Affairs Consultations (R&D), review staff of the review office in charge is present as needed. Pre-consultation meetings are free of charge.
Implementation method and location
- The meeting is done by a face-to-face, online, or a combination of both(hybrid meeting). Fill in the application form with the desired implementation method and location. Please note that your request may not be met due to circumstances such as meeting room and equipment. (If you wish to do by the online meeting, please select the location where you wish to do it.)
- In the case of the face-to-face meeting, some PMDA staffs may participate in the meeting online.
- In the case of the face-to-face meeting, the meeting will be conducted at the desired location among the following:
- Tokyo
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo
Pharmaceuticals and Medical Devices Agency - Osaka
Nakanoshima Qross The Future Medical R&D Center 6F, 4-3-51 Nakanoshima, Kita-ku, Osaka-shi, Osaka
Pharmaceuticals and Medical Devices Agency Kansai Branch - Kobe
Kobe Translational Research Informatics Center 2F, 1-5-4, Minami-cho, Chuo-ku, Kobe-shi, Hyogo
PMDA Strategy Consultation and Coordination Center, Foundation for Biomedical Research and Innovation at Kobe
- Tokyo
- If you wish to use the online meeting (including when it is combined with a face-to-face meeting), please refer to "2. Method of Application" and submit "Basic Confirmation Items for Implementation of Consultations via Online Meeting".
Method of application
Submit the "Application Form for Questions of Regulatory Science Strategy Consultation Pre-consultation meeting " and materials regarding the consultation items and contents by e-mail. Regardless of the location, the submission destinations are the same.
Notes:
Please submit the application form after confirming that there are no mistakes in the contents of the application form, especially in the contact information (e-mail address, telephone number, etc.) of the person in charge.
Form download, etc.
- Application Form for Questions of Regulatory Science Strategy Consultation Pre-consultation meeting. Refer to Review Categories for New Drugs, Medical Devices and Regenerative Medical Products[191KB] for the field of responsibility.
- If you wish to hold an online meeting, please submit the "Basic Confirmation Items for Implementation of Consultations via Web Meeting" together with the above application form.
Destination of submission
Division of Innovation Support and Pharmaceuticals Affairs Consultations (R&D), Review Management Office
E-mail : yakujisenryaku[at]pmda.go.jp (Please replace [at] with @ when you send an e-mail)
Note 1: Mail subject should be "RS Pre_[University Name]_[Applicant Name]" or "RS Pre_[Company Name]".
Note 2: It may take more than five business days to answer, because the person and the field in charge are selected according to the content of the consultation.
Note 3: Incorrect e-mail addresses and spam prevention filters may prevent you from receiving e-mail.
Note 4: Our email system has a file size limit of 10MB. Emails exceeding this limit may not be delivered.
Time of acceptance
At any time
Notification of schedule, etc.
After the application form is received, the PMDA staff in charge will nortify the schedule by e-mail.
It may take more than five business days to contact the applicant, because appropriate persons in charge are selected according to the content of the consultation. Some questions may be answered by e-mail.
Conduct of Pre-consultation meeting
The meeting time is approximately 30 minutes per meeting. The number of atendeess is usually about 5 because of the size ot the meeting room. If you wich to athe number of visitors is larger, please indicate it on the application form (please note that your request may not met).
Others
The PMDA staff may make inquiries about the contents of questions in advance.
In addition, no records shall be prepared concerning the contents of the Pre-consultation meeting.