Pinnacle 21 announces the latest Validation Engine for submissions to Japan's PMDA!
As of 2026-Q1, this new Engine has been successfully deployed to production at the PMDA, who announced details recently via their public website (see section on Data Standards Catalog and CDISC Data Validation).
Now that the PMDA has made the announcement public, P21 can proceed to deliver this Engine to our user base.
Key details are as follows:
Health Agency | Japan's Pharmaceuticals and Medical Devices Agency |
Engine Name | PMDA 2411.1 |
Alias | PMDA Rules Version 6.1 |
Validity | Initial submissions 2025-04-01 onward |
Platform Compatibility | P21E 5.4.x and higher |
On the Data Package Configuration page, click the radio button for each Engine to see instructional notes, applicable dates, etc.
📚 Resources & Downloads
See also:
What are Impact, Severity, and Type? – PMDA uses "Severity," FDA does not.
Which Validation Engine should I use? – General Engine information.
Download the full release notes via the Validation Engine Changelog.
If you have any questions, or would like counsel for your upcoming submissions, reach out to your Customer Success representative or our Enterprise Service Desk.
P21's default stance is to promote "the latest and greatest" standards, Engines, and best practices. However, defer to your team's agreements with the PMDA reviewers if a specific Engine has been agreed upon for a specific in-progress submission. 🇯🇵
👣 What’s Next
Learn more in the Validation & Issue Management Collection.
Email questions or feedback to support@pinnacle21.atlassian.net.