Drug Evaluation Committee Meeting on Smooth Implementation of Electronic Data Submission: "Results of Questionnaire on Consultation on Exemption from Electronic Data Submission" and "Information Sharing on SDTMIG v3.3 and Define-XML v2.1".
June 2024
The Data Science Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) Task Force 6 for Fiscal Year 2023 has been working to promote the smooth submission of electronic application data and the effective utilization of CDISC-compliant data, in light of changes in the environment surrounding the submission of electronic application data.
As part of these activities, we held a “Workshop on Ensuring the Smooth Implementation of Electronic Data Submission for Regulatory Applications” in March 2024 for member companies of the Data Science Subcommittee. This event served as a forum for those involved in electronic data submission to discuss “how to carry out their work smoothly” and to exchange information on challenges encountered in their daily operations.
We are making the presentation materials for the following two topics—presented at this meeting as the results of the task force—publicly available. We hope these materials will serve as a useful reference for information gathering and operations at each company.
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee
Data Science Subcommittee FY2023 Task Force 6