10th Annual Meeting DIA Japan 2013

FDA has utilized submitted data in CDISC format and plans to mandate the CDISC data submission for all sponsors. It is expected that, by utilizing CDISC data, the J-NDA reviews and consultation meetings would become more efficient and regulatory science studies using accumulated data would be activated, e.g., modeling and simulation. “Japan Revitalization Strategy -JAPAN is BACK-”, which states Eliminate Lag by 2020, was approved in a Cabinet meeting on June 14, 2013. The Strategy for Health and Medical Care states “PMDA should actively work on analyses and research of clinical data and construct more sound and efficient evaluation/decision processes at the review and the consultations. “ To achieve these goals, it becomes increasingly important for every stakeholder to use CDISC standards in Japan as well. Because CDISC standards are the unique global standards, Japanese data in CDSIC format would contribute to global health and medical care. This session will provide presentations by PMDA, industry, CDISC community in Japan and ARO, and discuss on current situations, a future direction, and challenges.