Abstract
The Japan Revitalization Strategy indicated that it is essential to strengthen the system of the PMDA with respect to both quality and quantity, and the Healthcare and Medical Strategy (an agreement among relevant ministers, June 14, 2013) further states that PMDA shall promote its analyses and research by utilizing study data (e.g., clinical data) and shall establish a rational and efficient process for making evaluations and decisions in its reviews and consultations. In order for PMDA to take initiative to conduct its analyses and research using data, it is important for the clinical data, first of all, to be submitted in an electronic format. Collecting clinical study results in the format of electronic data will enable various analyses to be conducted in application reviews for individual products, which will allow more objective and scientific decisions to be made and further contribute to an increase in the quality of its reviews. Uniform methods of collecting study data from various products will also allow product cross-sectional evaluations and may enable utilization of modeling and simulation. Meanwhile, electronic clinical study data submission on an application is thought to provide many advantages for the applicants as well. This article summarizes the current status on constructing the advanced review/consultation framework in Japan.
