Drug Evaluation Committee
Survey and Discussion on the Current State of Digital Health in the Pharmaceutical Industry
(1) Current status and issues of digital health - how pharmaceutical companies should tackle them
2) Current status and points to consider in the development of digital therapeutics (DTx)
Significance of using digital biomarkers (dBM) in drug development and practical procedures
Clinical Evaluation Subcommittee
June 2023
The recent progress of digital technology has been remarkable, and the development and utilization of digital health products, such as digital therapies and digital biomarkers, are becoming increasingly active in the healthcare field as well. The Clinical Evaluation Subcommittee Task Force 1 for FY2022 has prepared the following three documents on the topic of digital health in the pharmaceutical industry, which we hope you will read.
(1) Current Status and Challenges of Digital Health - Pharmaceutical Companies' Approach (1.46MB)
In the hope of helping pharmaceutical companies to engage in digital health business, we have summarized product categories, case studies, domestic and international regulations, business development, etc., with the scope of digital health in general.
2) Current status and points to consider in the development of digital therapeutics (DTx) (1.29MB)
Focusing on the DTx development process, the report examines regulations, domestic and international development cases, and summarizes issues and points to keep in mind regarding data packages for regulatory approval and clinical trials.
Focusing on dBM in drug development, we reconfirmed the significance of its utilization, and summarized practical procedures such as preparation and issues for clinical trials, including prior cases and various guidelines.
Deliverables of the Drug Evaluation Committee Return to list of all deliverables