Japan CDISC Coordinating Committee Update

Japan CDISC Coordinating Committee Update

Hidetoshi Misawa (Pfizer Japan Inc.) chaired a session titled “Impact to NDA Preparation and Approval Review by Initiation of the Submitted Electronic Data” at the 2016 DIA Japan Annual Meeting in November. With the PMDA now accepting the submission and review of electronic study data, differences between PMDA and FDA requirements for electronically submitted study data have arisen, making it necessary for some companies to convert past study data in CDISC format.

This session addressed what this will change in both industry’s NDA preparation process and the regulator’s review process. It also determined answers to such questions as: “What study data is most appropriate for NDA?”, “How should applicants prepare the NDA dossier?”, “How will the submitted electronic study data impact business and review timelines?” and “How should companies address these changes?” Panelists representing industry and regulatory perspectives discussed these emerging issues from the standpoint of regulation and data science.

Panel Discussions and Speakers included:

Implementation of Advanced Review with Electronic Study Data in PMDA

Mayumi Shikano, PhD, Associate Director, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA)

Impact to NDA Preparation and Approval Review by Initiation of the Submitted Electronic Data

Natsuko Hamada, Regulatory Scientist, Therapeutic Area Regulatory, Japan Regulatory Affairs, Medicines Development Unit Japan, Eli Lilly Japan K.K.

E-Data Submission - Make It Happen

Azusa Tsukida, Head, Biostatistics & Programming, Clinical Sciences & Operations, Research & Development, Sanofi K.K.

Update on Required Study Data Standards: Technical Rejection of Submissions (Presentation through Internet)

Ron D. Fitzmartin, PhD, MBA, Sr. Advisor, Office of Strategic Programs, Center for Drug Evaluation and Research, US FDA

The presentations and discussions included but were not limited to the following topics.

  • Efficient utilization of electronic study data will ultimately benefit the public
  • Clearer explanation about ultimate goals of PMDA e-Sub requirements would be helpful for the Japan industry to understand the need of investment.
  • e-Submission to PMDA is NOT just about work for DM/Programing group. It should be a joint effort across groups (e.g., Clinical, Regulatory, Project Management, DM/Programing).
  • Differences in regulatory requirements between PMDA and FDA is an issue and the gap should be decreased.
  • Priority and flexibility (e.g., which studies and/or which analysis datasets should be submitted) should be considered to effectively use resources and costs both in Japan industry and PMDA.
  • Open, honest and efficient communication should continuously take place between PMDA and the Japan industry based on real-world experiences.