[SHINSA]"Consultations" Updated

The PMDA offers formal (fee-based) consultations to universities, research institutions, and companies that develop medical products to give guidance and advice on various issues.

In clinical trial consultations for new drugs, the PMDA not only ascertains whether a planned clinical trial complies with the requirements for regulatory submission, taking into consideration the ethical and scientific aspects of and the reliability of the clinical trial as well as the safety of trial subjects, but also gives advice that leads to an improvement in the quality of the clinical trial.

The PMDA’s formal consultations for medical devices and regenerative medical products are also provided to give guidance and advice on clinical trial protocols and data packages for regulatory submissions.

Formal consultation on R&D or regulatory submission involves consultation fee, while topics to be discussed in such consultations can be clarified free of charge in a Pre-consultation meeting.
For information on consultation fees, please refer to the “Fee for Formal Consultation” page.
Please note that fees may be changed without notice.

Furthermore, the PMDA provides universities, research institutions, and venture companies with guidance and advice on pre-proof-of-concept studies, clinical trial protocol development, and other issues. For more information, see “RS General Consultation and RS Strategy Consultation” page.

PMDA Consultation Handbook provides guidance on how to use PMDA consultation services, when seeking marketing authorization for pharmaceuticals, including vaccines, in Japan.
The handbook also includes practical information for overseas developers, including considerations on “Interpretation” and “Importance of Identifying a Development Partner in Japan”.
For details on PMDA consultation services, please refer to the handbook.
PMDA Consultation Handbook（Japanese Original Version 1.1）[5.8MB]／PMDA Consultation Handbook（English Version 1.2）[6.4MB]