Consultation category
RS strategy consultation is categorized as follows. Consultation is charged.
Strategy consultation of drugs
Strategy consultation of medical devices
Strategy consultation of regenerative medical products
Mainly for universities, research institutes, and venture/start-up companies, guidance and advice are provided on the studies and clinical trial plans required for drugs, medical devices (including in vitro diagnostic reagents), and regenerative medical products from the final stage of selection of candidates for development to the initial stage of clinical development (proof of concept (POC) studies (Phase IIa)).
In the event that a university or research institute conducts a study on its own and the product meets all of the following requirements and has high medical needs, consultation will be provided for confirmatory clinical trials after the initial stage of clinical development.
- The product must be considered or selected by the " Study Group on Unapproved and Off-label Drugs of High Medical Needs " or " Study Group on the Early Introduction of Medical Devices, etc. with High Medical Needs "
- The cost of all of a confirmatory clinical trials shall be covered by public research funds (including cases where part of the cost is covered by a matching funds, etc.).
In each of the consultation categories, guidance and advice will be provided on cases involving data evaluation for necessary studies, etc., from the initial stage of development to approval.
- Strategy consultation of drugs: In principle, only when drug candidate compounds or compounds with certain activities are obtained.
- Strategy consultation of medical devices (including in vitro diagnostics): In principle, only when there are prototypes; specifications, designs and layout are roughly decided.
- Strategy consultation of regenerative medical products: in principle, only when candidates for products such as regenerative medical products, or prototypes with a certain degree of efficacy are obtained.
Consultation on the quality and safety of regenerative medical products
Guidance and advice are provided to regenerative medical products or live genetically modified vaccines (products intended to express the transgene in humans for the purpose of preventing disease (excluding regenerative medical products) from the initial stage of development to the time of clinical trial notification.
In this consultation category, consultation may be provided more than once. The fourth or subsequent consultation by a company that does not receive the application of reduced fee is regarded as an "Additional consultation on the quality and safety of regenerative medical products" and an additional consultation fee is required.(Please refer to the Implementation Guide for details.)
Consultation outside the scope of this consultation, such as the clinical study protocol of the products specified above, will be provided in the consultation category of the Strategy consultation of drugs, medical devices, regenerative medical products: to which the product concerned belongs.
Reference: Matters to be noted for efficient consultation on the quality and safety of regenerative medical products, etc. (Checkpoints)
If you wish to consult about the quality and safety of products such as regenerative medical products, etc., please prepare the data referring to the following.
Thechnical Guidance
Cellular and tissue-based products
- Quality: Points to consider (checkpoints) for efficient conduct of RS strategy consultation for quality and safety from early stage of development of cellular and tissue-based products [Quality][271KB]
- Non-clinical Safety: Points to consider (checkpoints) for efficient conduct of RS strategy consultation for quality and safety from early stage of development of cellular and tissue-based products [Nonclinical safety][173KB]
Gene therapy products
- Quality: Points to consider (checkpoints) for efficient conduct of RS strategy consultation for quality and safety from early stage of development of gene therapy products [Quality][336KB]
- Non-clinical Safety: Points to consider (checkpoints) for efficient conduct of RS strategy consultation for quality and safety from early stage of development of gene therapy products [Nonclinical safety][146KB]
Sterility testing and mycoplasma testing
Strategy consultation on the development plan
Provide guidance and advice on general concepts and procedures for study plans, such as roadmaps for development plans. Specific development plans for individual products (sufficiency of non-clinical studies, appropriateness of evaluation items of clinical studies, etc.) are handled by the Strategy consultation of drugs/medical devices/regenerative medical products.
Implementation method and location
The consultation is done by face-to-face, online, or a combination of both (hybrid meeting) etc.. Fill in the desired implementation method and location on the application form (refer to "Implementation method" within "4. Scheduling Request ").
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
Note: The Videoconferencing System is available for use in the Kansai Branch. In this case, the participants from the Consulter can be divided into two groups: Tokyo and Osaka. For details, refer to "How to Use the Video Conferencing System" of the Kansai Branch.
Consultation flow and products subject to Consultations
Consultation flow
When applying for RS strategy consultation, please apply for a Pre-consultation meeting (free of charge) and arrange the points of discussion in the consultation and confirm the content of materials with the person in charge of the PMDA. Based on the results of the Pre-consultation meeting, the applicant will apply for a consultation.
For details of the Pre-consultation meeting, please refer to the "Pre-consultation meeting for RS strategy consultation" page.
The application procedure has a schedule (due date) for each procedure. Please check the schedule carefully. (For example, Request form for Scheduling of RS strategy consultation, which is the first procedure, will be accepted only on the specified date at the beginning of the month, until 4:00 p.m. JST, except for some consultations.
Scheduled Date of Acceptance is here(available in Japanese only)[229KB]）
Subject to consultations
The subject to consultation shall, in principle, fall under the priority fields (listed below) and be expected to be promising (for example, in the case of drugs, a substance patent is pending or has been obtained; in the case of medical devices, there are prototypes or specifications or designs are roughly decided; in the case of regenerative medical products, there are prototypes having a certain degree of efficacy; or in the future, there are highly likely to be put into practical application as innovative drugs, medical devices, or regenerative medical products). Provided, however, that depending on the status of receiving consultations at the PMDA, consultations other than the above may also be accepted.
(Priority Category)
Regenerative medical products, oncology products, intractable diseases and orphan diseases products, pediatric products, and other products using particularly innovative technologies (Note: Regardless of ranking among categories)
Request for scheduling
In principle, submit the "Request Form for Scheduling" for each consultation category to Office of Review Management by e-mail.
Enter the desired implementation method and, if you wish to hold a meeting online, submit the "Basic Confirmation Items for Implementation of Consultation via Online Meeting" together with the above application form.
E-mail: yakujisenryaku[at] pmda.go.jp (Please replace [at] with @ when you send an e-mail)
- The subject line of the e-mail should be " Request for scheduling_RS_’[University Name]_[Applicant Name]" or "Request for Scheduling_RS_[Company Name]."
- The Request form for scheduling should be submitted in a text recognizable file (PDF, etc.).
- If you wish to apply for reduced consultation fee, please submit the request form for application of requirements for reduced consultation fee together with the above application form. (Refer to "5. Consultation Fees")
- Our email system has a file size limit of 10MB. Emails exceeding this limit may not be delivered.
Note:
Please submit the application form after confirming that there are no mistakes in the contents of application form especially in the contact information (telephone number, e-mail address) of the person in charge.
Request form for scheduling of RS strategy consultation
Strategy consultation of drugs
Strategy consultation of medical devices
Strategy consultation of regenerative medical products
Consultation on the quality and safety of regenerative medical products (Note)
Strategy consultation on the development plan
Note: Additional consultation on the quality and safety of regenerative medical products
The application procedure has a schedule (due date) for each procedure in advance. Please check the following schedule carefully.
- Scheduled date of reception is here (available in Japanese only)[229KB]
- Scheduled date for submission of the materials for Consultations is here (available in Japanese only)[214KB]
Implementation method
- Describe the desired implementation method (i.e., face-to-face or online) on the Request form for scheduling of strategy consultation.
- If you wish to hold an online meeting, please submit the "Basic Confirmation Items for the Implementation of Consultation, etc., by Web Meeting" together with the "Request form for scheduling of strategy consultation".
- If an online meeting is to be held due to a consultation not desired an online meeting at the time of submission of the "Request form for scheduling", submit the “Basic confirmation items for implementation of consultations via online meeting” to the review staff form review office in charge at that time.
- The department in charge of consultation shall decide on the implementation method considering the meeting room and equipment, etc. Please note that your request may not be met. In the case of face-to-face meeting, some members of the PMDA may attend the meetings online.
Time of acceptance
Strategy consultation of drugs
Strategy consultation of medical devices
Strategy consultation of regenerative medical products
Usually until 4:00 p.m. JST of the first working day of the month 2 months before the month in which consultation is to be provided (must be delivered)
Note: Please refer to this section for the scheduled dates of reception.
Consultation on the quality and safety of regenerative medical products (including Additional consultation on the quality and safety of regenerative medical products)
Strategy consultation on the development plan
To accept as needed
Attachment (only consultation on confirmatory study)
In the case of Strategy consultation of drugs, medical devices, regenerative medical products, where the university or research institute conducts its own studies and requests consultation on confirmatory study after the initial stage of clinical development, attach the documents in "1. and 2. below to confirm that the product meets the requirements.
- List of items requested by the " Study Group on Unapproved and Off-label Drugs of High Medical Need " or the list of items selected by the " Study Group on the Early Introduction of Medical Devices, etc. with High Medical Needs " (by checking the relevant items so that the relevant items can be identified)
- The breakdown of public research funds covering all or part of Confirmatory study for the product concerned, materials that can identify the research theme, and a copy of the notice of grant decision.
Consultation fees
The following table shows the consultation fees per consultation.
| Category of consultation | Amount of commission | Fees for universities, research institutes, or venture companies that meet the requirements specified separately |
|---|---|---|
| Strategy Consultation of Drugs (Note 1) | 1,541,600 yen | 154,100 yen |
| Strategy Consultation of Medical Devices | 874,000 yen | 87,400 yen |
| Strategy Consultation of Regenerative Medical products | 874,000 yen | 87,400 yen |
| Consultation on the Quality and Safety of Regenerative Medical Products (Note 2) | 1,541,600 yen | 154,100 yen |
| Additional Consultation on the Quality and Safety of Regenerative Medical Products (Note 2) | 496,800 yen | Not Applicable |
| Strategy Consultation on the Development Plan | 73,600 yen | Not Applicable |
Note 1: Fees for in vitro diagnostics is charged for strategy consultation of medical devices.
Note 2: Consultation may be provided for multiple days to the extent necessary to sufficiently confirm the quality and safety of the product concerned before submitting a clinical trial notification. In this case, if a university or research institute or a venture company that meets the requirements specified separately is applicable, a fee equivalent to one consultation fee shall be paid. In the case of a venture company that does not satisfy the requirements specified separately, the consultation fee shall be equivalent to the fee for one consultation up to the third consultation if the consultation is conducted for multiple days. After the fourth consultation, the fee for Additional consultation on the quality and safety of regenerative medical products will be paid.
When a university, research institute, or venture/start-up company meets the requirements specified separately
Through national policies, universities, research institutes, and venture/start-up companies that meet the following requirements can receive RS strategy consultation at a reduced fee, with the aim of practical application of innovative drugs, medical devices, regenerative medical products. Consult the Office of Review Management if you wish to apply a low fee.
(Requirements for reduced consultation fee)
In principle, all of the following prerequisites have to be fulfilled.
- Universities and Research Institutes
- Having not received research expenses of the following amount or more for the relevant seed-stage resources from the government.
Strategy consultation of drugs or Consultation on the quality and safety of regenerative medical products: 90 million yen
Strategy consultation of medical devices or Strategy consultation of regenerative medical products: 50 million yen - Having not received research expenses from a pharmaceutical company/company developing medical device under a joint research agreement, etc. for practical application of the seed-stage resources
- Having not received research expenses of the following amount or more for the relevant seed-stage resources from the government.
- Venture and start-up companies
- An SME (i.e., the number of employees is 300 or less or the company’s capital is 300MM yen or less.)
- Another corporate body does not hold shares or capital contributions equivalent to one half or more of the total number of shares or the total amount of contributions.
- Two or more corporate bodies do not hold shares or capital contributions equivalent to two-thirds or more of the total number of shares or the total amount of contributions.
- Net profit is not recorded or is recorded without business revenue in the previous fiscal year.
Note: Please note the following points regarding the application of the low-cost requirement to venture companies.
- For "corporation" included in the above items related to venture companies, handling of investment unions such as venture capital firms is determined individually in accordance with the relevant laws and regulations, standards, etc.
- If development expenses are recorded as deferred assets for accounting purposes, the amount equivalent to the current profit in the case of processing them as expenses is used as a reference.
- If there are special circumstances, etc. in the settlement of accounts for the preceding business year and it is considered necessary to make a judgment based on the settlement status in the preceding two fiscal years, you may be requested to submit the related materials and judgment is made after confirmation of these materials.
When requesting for application of requirements for reduced fee
When applying for the fee classification of the above "universities, research institutes, venture/start-up companies that meet the requirements specified separately," please submit the following " Request form for application of requirements for reduced consultation fee " by e-mail to the Office of Review Management. If it is difficult to submit by e-mail, please contact the Office of Review Management. In addition, if the data size is large, you may submit it by mail or by bringing it in. In this case, write " Request Form for Application of Requirements for Reduced Consultation Fee for RS Strategy Consultation" in red in the table of the envelope.
Based on the submitted materials, the applicability of the requirements for reduced consultation will be confirmed, and the applicability of the requirements and the commission classification will be notified.
- E-mail : yakujisenryaku[at] pmda.go.jp ([Please replace [at] with @ when you send an e-mail)
- Please submit together with the "Request form for scheduling of RS strategy consultation".
- Our email system has a file size limit of 10MB. Emails exceeding this limit may not be delivered.
Request Form for Application of Requirements for Reduced Consultation Fee
The seal of the applicant is not required.For universities and research institutes
- Application form
- The breakdown of all research expenses incurred by the representative of the research concerned with respect to the seeds, materials that can identify the research theme, and a copy of the notice of grant decision (for the three business years including the previous business year).
For venture/start-up companies
- Application form
- A copy of the business report, the balance sheet, the profit and loss statement, and the corporation tax return in Appendix 2 (or list of shareholders (investors)) for the previous business year. Provided, however, that in the event the capital is 300 million yen or more, documents that can confirm the number of employees, such as a copy of application form for rough estimate of insurance premium for labor insurance.
Time of acceptance
Must arrive on the acceptance date of the request form for scheduling.
Notification of the consultation date
After receiving the request form for scheduling, the person in charge of PMDA will contact the applicant for the adjustment of the implementation date and time. When the date, time, and place of implementation have been determined, the person in charge of PMDA will inform the applicant.
However, consultation on GMP standards may involve visits to manufacturing facilities, etc., and it may take some time to determine the date and time of Consultation. Therefore, even if the date and time of consultation are determined, the deadline for submission of application forms may be notified.
Payment of fees and submission of application form
In principle, submit an "Application for RS strategy consultation" by consultation category to the Office of Review Management by e-mail within 15 working days counting from the day following receipt of the nortification of the date of implementation mentioned in "6 Notification of the consultation date" above or within the earlier of the date of delivery of the documents, with a copy of the receipt of the transfer fee.
- E-mail : yakujisenryaku[at]pmda.go.jp (Please replace [at] with @ when you send an e-mail)
- The subject of the e-mail should be "Application form_[Acceptance number]_[university name]_[Applicant's name]" or "Application form_[Acceptance number]_[company name]".
- Submit the application form in a text-recognizable electronic file (e.g., PDF).
- Our email system has a file size limit of 10MB. Emails exceeding this limit may not be delivered.
Note:
Please submit the application form after confirming that there are no mistakes in the contents of the application form, especially in the contact information (telephone number, e-mail address) of the person in charge.
Application form
Strategy consultation of drugs
Strategy consultation of medical devices
Strategy consultation of regenerative medical products
Consultation on the quality and safety of regenerative medical products (Note 1)
Strategy consultation on development plan
Note: Includes "Additional consultation on the quality and safety of regenerative medical products".
Submission of consultation material
Documents for RS strategy consultation should be submitted to the Office of Review Management. Submission by e-mail is not accepted. When preparing materials, refer to the following preparation methods.
Provided, however, that the submission of documents is not required for strategy consultations on the development plans, etc., but inquiries about the contents of questions may be submitted in advance.
- Method of submission of materials:
Submit by one of the following methods.
Before submitting the consultation materials, please confirm the following points in advance.- Mailing or bringing electronic media (one copy of CD or DVD)
- On-line submission using an electronic data system (gateway system)
Note 1: If necessary, you may be requested to submit materials printed.
Note 2: Multiple copies may be requested if necessary.
- Due date for submission of materials:
In principle, submit by the following date and time. In principle, the submitted data will be disposed by the PMDA.- Strategy consultation of drugs, Strategy consultation of regenerative medical products, Consultation on the quality and safety of regenerative medical products (including Additional consultation on quality and safety of regenerative medical products)
By 3:00 p.m. JST on the first working day of the week 5 weeks prior to the scheduled date of the consultation - Strategy consultation of medical devices
By 3:00 p.m. JST on the first working day of the week 3 weeks prior to the scheduled date of the consultation
- Strategy consultation of drugs, Strategy consultation of regenerative medical products, Consultation on the quality and safety of regenerative medical products (including Additional consultation on quality and safety of regenerative medical products)
Note:
If long holidays (a long weekend in Japan in late April and early May, year-end and New year holidays, etc.,) are included during the five weeks before the RS strategy consultation (or three weeks in the case of a Strategy consultation for medical devices), the date of submission of the materials may be earlier.
(Method of preparation of materials to be submitted and points of attention when submitting materials)
Request: Materials for Consultations to be delivered (available in Japanese only)[293KB]
Until now, problems have occurred, such as the inability to read CDs and DVDs, and corrupted files.
Confirm that electronic files can be read on a PC other than the PC that created the CD or DVD (Windows OS) before submitting it.
Method of Submission of Materials of Consultations and Notes (available in Japanese only) [473KB]
Be sure to read before submission via the gateway system.
Conduct of consultations
- The PMDA staff may make inquiries about the contents of the consultation in advance.
- The PMDA will present its views on the content of "Strategy consultation of drugs", "Strategy consultation of regenerative medical products", and Strategy consultation on the quality and safety of regenerative medical products" (including "Additional consultations on the quality and safety of regenerative medical products") in writing before consultation. If the applicant and the PMDA agree, the consultation may be terminated with written advice and may not be held.
- Contact the PMDA staff by the day before the date of consultation, regarding the number of participants, the presence of experts on the consulter side or non-Japanese speakers (including the presence or absence of interpreters), and the equipment to be used in the presentation.
- Due to the size of the meeting room, the number of participants per consultation shall not exceed 15.
- Follow the instructions of the person in charge when visiting.
- Consultation time shall be within two hours per consultation. Provided, however, that "Strategy consultation on the development plan" shall be held for approximately 30 minutes.
- On the meeting, please give a presentation on the outline of the consultation items for about 10 minutes. Provided, however, that a presentation shall be made in about five minutes in the case of "Strategy consultation on the development plan". Afterwards, consultation is provided. For the timing of submission of presentation materials, please consult a PMDA staff in charge beforehand.
Please check the following precautions in advance when visiting the PMDA.
Request for Persons Visiting the PMDA for Consultations [99KB]
Consultation record
After the consultation is provided (including when the consultation is completed with written advice), the PMDA will prepare a consultation record and send it to the consulter after confirming the details.
Review category of new drugs, medical devices and regenerative medical products
Review Category for New Drugs, Medical Devices and Regenerative Medical Products [191KB]
Withdrawal, request for refund
Note:
Please submit the application form after confirming that there are no mistakes in the contents of the application form, especially in the contact information (telephone number, e-mail address) of the person in charge.
Withdrawal and refund of Consultation
If the application for RS strategy consultation is to be withdrawn for the convenience of the applicant after the application date, submit the "Request for Withdrawal of Application for Consultations". In addition, when the "Request for Refund of Review Fee for Drugs, etc." is submitted, half of the fees shall be refunded.
Applicant's seal is not required.
- Request on Withdrawal of Application for Consultation（Word format）[29KB]
- Request form for Refund of the Examination (Drugs, etc.) Fee（Word format）[58KB]
Submitted to: Office of Review Management
Request for refund by mistake
In the event that a difference arises between the fee paid in and the original fee amount due to a division error, the amount of such difference shall be refunded.
Applicant's seal is not required.
Document submission address and contact information
- Regardless of the location of the consultation (Tokyo or Osaka), the submission address and the contact point are the same.
- The reception hours for inquiries are from 9:30 a.m. to 5:00 p.m. JST on weekdays.
Where to submit the documents or inquiries about the contents of the consultation
Division of Innovation Support and Pharmaceuticals Affairs Consultations (R&D), Office of Review Management, Pharmaceuticals and Medical Devices Agency:
〒100-0013 Shin-kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo
E-mail：yakujisenryaku[at]pmda.go.jp (Please replace [at] with @ when you send an e-mail)