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

April 2026

The Task Force on Ongoing Issues of the Evaluation Subcommittee of the Drug Evaluation Committee (Team for the Collection and Analysis of Pharmaceutical Development-Related Information) has been continuously surveying and analyzing the clinical data packages of products approved in Japan since fiscal year 2010, with the aim of formulating recommendations for optimizing clinical data packages.
This fiscal year, we again updated and released the database of approved products on a quarterly basis, based on publicly available information from the PMDA. We have also prepared an introductory document for this database; please refer to it as needed.
Furthermore, regarding products developed through international collaborative clinical trials, we have illustrated the structure of the clinical data packages for products approved through fiscal year 2019 and compiled the details into a report.
*As of September 2026, we have suspended updates to the database of approved products published since April 2026, as we are currently reviewing future data collection and analysis methods, as well as the frequency of updates.
Once our future policy has been finalized, we will announce it on the JPMA website.

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