RS general consultation is a free consulting service for academia and venture/start-up companies, etc., who are not accustomed to the Pharmaceutical and Medical Devices Act and PMDA's consultation and review. Please feel free to apply for it!
In the RS general consultation, the appropriateness of consultations at the PMDA (RS strategy consultation, etc.) is confirmed and general explanations and consultations on guidelines, notices, systems, etc. that will be used as reference for approval applications are provided. In addition, on April 1, 2018, a "Consultation for Collaboration on Innovation and Implementation" (information sharing with Venture Support Strategy Office, Policy Planning Division for Pharmaceutical Industry Promotion and Medical Information Management, Health Policy Bureau, Ministry of Health, Labour and Welfare) was commenced.
RS general consultation is provided free of charge. Please feel free to apply!
Implementation method and location
- The consultation 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 or equipment.
(If you wish to do by the online meeting, please select the location where you wish to do it.) - In the case of face-to-face meeting, some PMDA members may attend the meeting online, and the meeting will be held at the desired location among following:
- Tokyo
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo - 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 hold an online meeting (includiong when it is combined with a face-to face meeting), please refer to "2. Methods of application" and submit "Basic Confirmation Items for Implementation of Consultation via Online Meeting".
Method of application
Submit the "Application Form for Questions on Regulatory Science General Consultation " and materials regarding the product and the content of the consultation 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.
Download form, etc.
- Application Form for Questions on Regulatory Science General Consultation
- If you wish to hold an online meeting, please submit the "Basic Confirmation Items for Implementation of Consultation via Online 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 General_[University Name]_[Applicant Name]” or “RS General_[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 notify the schedule by e-mail. (Usually, the meeting date is two weeks or more from the date of entry.)
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.
Depending on the question, it may be answered by e-mail.
Conduct of RS general consultation
The consultation time is approximately 20 minutes per consultation. The number of visitors is usually 2 to 3 because of the size of the meeting room. If you wish to attend the meeting with more attendees, please indicate on the application form beforehand (please note that your request may not be met).
Others
The PMDA staff may make inquiries about your questions in advance.
If you wish to "Consultations for collaboration in the practical application of innovation", please indicate this in the remarks column of the application form.
In addition, no records shall be prepared concerning the contents of the RS general consultation.