Drug Evaluation Committee Survey and Analysis of Clinical Data Packages for Approved Drugs
Clinical Evaluation Subcommittee
October 2025
The Ongoing Issues Team (Team for Collection and Analysis of Information Related to Drug Development) of the Evaluation Committee of the Drug Evaluation Committee 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 FY 2019 and compiled the details of the clinical data package 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 |
Introduction of Database
Introduction of Database of Approved Products (DB) (949KB)
Report
Detailed Survey of Clinical Data Packages Including International Clinical Trials in FY2019 (2.3MB)
Poster
Reference: Previous reports
- FY 2018 Detailed Survey of Clinical Data Packages Including International Clinical Trials (921KB)
- FY2017 Detailed Survey of Clinical Data Packages Including International Clinical Trials (1.1MB)
- FY2016 Detailed survey of clinical data packages including international clinical trials (860KB)
- FY2015 Detailed survey of clinical data packages including international clinical trials (676KB)
- Detailed survey of clinical data packages including global clinical trials for FY2014 (424KB)
- Detailed survey of clinical data packages including international clinical trials for FY2013 (429KB)
- FY2013 Survey and analysis of clinical data packages for approved items (369KB)
- FY2012 Utilization of Foreign Data in Clinical Data Packages - Detailed Survey and Analysis of Clinical Data Packages for Products Approved in Japan - (573KB)
- FY2011 Survey Report on Usage of Foreign Clinical Data in Clinical Data Packages for Approved Products in Japan - Detailed Survey and Analysis (824KB)
- FY2010 Survey Report on Strategy for Establishment of Clinical Data Package and Review Process (1.1MB)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables