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.
In this regard, PMDA started a discussion in the view of mandating electronic submissions in the future, and internally established "Task force for advanced review and consultation with electronic data" on Sept 1st, 2013.
On Apr 1st, 2014, the task force was raised to "Advanced Review with Electronic Data Promotion Group" as an official department of PMDA.
This webpage provides related information about our new approach.
*Regarding the submission of data for the FY2015 Pilot Project
・We initially announced the closing date of the application period for the FY2015 pilot project to be March 31, 2015 in the document “Re: Request for Electronic Clinical Study Data for Pilot Project (FY 2015)” (PMDA/CPE Notification No. 1001001, October 1, 2014).
・However, considering the current status of applications in each therapeutic area for the FY2015 pilot project, we have decided to extend the closing date of the application period to September 30, 2015.
・Please note that we may not be able to accept some of the additional applications for the pilot project, depending on the application status and the workload of each new drug office at that time. We would highly appreciate your willingness to participate, but we might have to request that you refrain from your application under such circumstances.
・If you are interested in participating in this project, we would appreciate it if you could contact us as soon as possible and let us know the details of your application (such as the therapeutic area of the drug and the timing of your data submission).
・We accept data of new drug products that are submitted to regulatory review in Japan as well as data of new drug products that are already approved, currently under regulatory review or scheduled to be reviewed after this pilot project.
・We welcome applications for clinical data in conformance to CDISC with only ONE STUDY and population analysis data (PK and/or PK/PD) with only ONE ANALYSIS.
・We also welcome applications even if you can only provide either one of clinical data in conformance to CDISC or data for population PK and/or PK/PD analysis.
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.)