“Regulatory Science general consultation (RS general consultation)” and “Regulatory Science strategy consultation (RS strategy consultation)” provide guidance and advice mainly for universities, research institutes, and venture companies, regarding the studies and clinical trials plan, etc. required for the development of drugs, medical devices 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 (early phase II studies)).
Regarding the quality and safety to be checked before submitting a clinical trial notification for a genetically engineered live vaccine (a product intended to express the transgene in humans for the purpose of preventing disease) or a product such as regenerative medical products, guidance and advice will be provided through the RS strategy consultation "Consultation on the quality and safety of regenerative medical products" (Consultation on quality and safety can also be provided through Consultation other than RS strategy consultation).
Brochure
Type of consultation
In order to efficiently provide RS strategy consultation (fee-based) for carrying out scientific discussions, Pre-consultation meetings (free of charge) are conducted to sort out the points to be discussed and check the content of the materials. RS general consultations (free of charge) include confirmation of whether or not the content of the consultations is subject to RS strategy consultations, explanations of application procedures, and general consultations concerning the Pharmaceuticals and Medical Devices Act, etc.
RS general consultation
- Technical experts from the Division of Innovation Support and Pharmaceuticals Affairs Consultations (R&D) or the Kansai branch consultation division explain the details and procedures of the RS strategy consultation service as well as confirmation of the appropriateness of the desired consultations to those who are not accustomed to PMDA's consultation and review.
- In response to questions about the Pharmaceuticals and Medical Devices Act and PMDA reviews, general explanations are provided.
- RS general consultation is provided free of charge.(There is no limit on the number of the consultations, but we may recommend the next step to move forward.)
- Please refer to the "RS general consultation" page for details.
Pre-consultation meeting for RS strategy consultation
- In order to ensure efficient RS strategy consultations, Pre-consultation meetings are held in advance to sort out the content (scope) and points for discussion in RS strategy consultation, as well as to confirm the content of documents. (In principle, all persons who intend to apply for RS strategy consultation should receive Pre-consultation meeitng.)
- In addition to technical experts from the Division of Innovation Support and Pharmaceuticals Affairs Consultations (R&D), review staff of the review office in charge are present as needed.
- However, that if the meeting is conducted in Kansai branch, the review staff will participate in the meeting online (free of charge).
- Pre-consultation meeting is free of charge.
- Please refer to the "Pre-consultation meeting for RS strategy consultation" page for details.
RS strategy consultation
- The review team of the review office carefully checks the documents submitted by the applicant, issues the official opinion of the PMDA on the matters to be consulted concerning future clinical trials and applications for approval, and provides specific guidance and advice.
- However, as a rule, technical experts from the Division of Innovation Support and Pharmaceuticals Affairs Consultations (R&D) provide Strategy consultations on development plans with the participance of review staff from the review office in charge as necessary.
- Consultation will be provided for a fee.
- RS strategy consultation is consist of five categories: Strategy consultation of drugs, Strategy consultation of medical devices, Strategy consultation of regenerative medical products, Consultation on quality and safety of regenerative medical products, and Strategy consultation on the development plan.
- Please refer to the "RS strategy consultation" page for details on the content of the consultation and the subject persons
Status of implementation
Results from April 1, 2019 to March 31, 2024(available in Japanese only) [160KB]
Address for application and inquiry
- Applications and inquiries are common regardless of the place of consultation (Tokyo, Osaka and Kobe).
- The reception time for inquiries is from 9:30 a.m. to 5:00 p.m. JST(UTC+9) on weekdays.
Destination for submission of applications, etc. and contact information
E-mail： yakujisenryaku[at]pmda.go.jp (Please replace [at] with @ when you send an e-mail.)