Drug Evaluation Committee Survey and Analysis of Clinical Data Packages of Approved Products

Clinical Evaluation Subcommittee

January 2026

The Drug Evaluation Committee's Evaluation Subcommittee's Ongoing Issues Team (a team that collects and analyzes information related to drug development) has been continuously surveying and analyzing clinical data packages of items approved in Japan since FY2010, with the aim of making recommendations for the optimization of clinical data packages.
This fiscal year, the team has released a database of approved items, updated quarterly based on publicly available information from the PMDA. We have also prepared introductory materials for this database, so please refer to them as necessary.
In addition, for items using international clinical trials, we have illustrated the structure of the clinical data package for items approved by FY2019 and summarized the details in a report.

Documents

Publication Period (4 times a year)	Items to be added
Jan.	Items approved between July and September of the previous year
Apr.	Items approved between Oct. and Dec. of the previous year
Jul.	Items approved between Jan. and Mar. of the current year
Oct.	Items approved between April and June of the current year