Evolving Real-World Data and Evidence Use for New Drugs and Regenerative Medical Products Approvals in Japan-An Analysis of the 6-Year Trend.

ABSTRACT: Several regulatory initiatives have been made to clarify the acceptability and requirements of real-world data and real-world evidence (RWD/E) for the benefit/risk assessment of new medical products in Japan. The objectives of this review were to characterize the use of RWD/E in regulatory applications of new medical products and to describe the longitudinal trends of how use cases evolved in conjunction with regulatory initiatives in the most recent 6 years in Japan. New drugs and regenerative medical products applications approved by the Ministry of Labour, Health, and Welfare between January 1, 2019, and December 31, 2024, were included (N = 674). Of these, 158 (23.4%) applications contained RWD/E. The number of RWD/E use cases increased continuously over the period from 21 (18.1%) of a

SUBMITTER: Okami S 

PROVIDER: S-EPMC12641076 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature