In recent drug development, the use of data-based quantitative information such as those using modeling and simulation (M&S) methods has been proactively promoted in decision-making process.
Under such circumstances, PMDA recognizes the need for accumulating electronic study data, analyzing the data by advanced methods, and making use of the data in the process of its reviews and consultations. The use of such accumulated data is expected to reduce the workload of regulatory submission for sponsors, improve PMDA's evidence-based reviews and consultations, and lead to development of new guidelines, which will eventually result in the rise of the success rate of drug development.
This webpage provides related information about our new approach.
For any inquiries on this page, please send your message to this address.
(Please note that not all inquires would be answered respectively. Thank you for your understanding.)