In PMDA‘s Fifth Mid-term Plan (FY2024-FY2028), we will implement consultation services and reviews that appropriately respond to innovation, such as issuing Early Consideration and formulating clinical evaluation guidelines based on the latest scientific knowledge, and will compile and publish on this website Early Consideration and other documents on issues such as the practical application of innovative technologies and the development and evaluation of pharmaceuticals.
Early Consideration is reference information and point of view at that time for promoting the practical application of new technologies and other innovations and the development of innovative pharmaceuticals, etc., although scientific knowledge and information have not yet been fully accumulated,
Please note that this information may change in the future based on new knowledge, scientific advances, etc.
The following English translations of Japanese Early Considerations are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail. The PMDA shall not be responsible for any consequence resulting from use of the English version.
- Check List for 30-day-Clinical Trial Notification Review on an Initial Clinical Trial Notification (Oncology Drugs)[241KB]
December 10, 2024
- Statistical Considerations When Planning Phase I Clinical Trials in Oncology - From the Safety Perspective (Early consideration) [197KB]
December 4, 2024 Office of Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency
- Points to Consider for the Design of Clinical Trials to Assess the Effects of Psychotropic Drugs on Driving Performance (Early consideration)[175KB]
August 15, 2024 Office of New Drug III, Pharmaceuticals and Medical Devices Agency
- Principles for the Evaluation of Vaccines Against the Novel Coronavirus SARS-CoV-2 (Appendix 5) Quality data required for the approval review of changing a strain in the vaccine for which the manufacturing process is well established (Early consideration) [108KB]
May 29, 2024 Office of Vaccines and Blood products, Pharmaceuticals and Medical Devices Agency