New PMDA Engine

Pinnacle 21 is happy to announce the latest Validation Engine for submissions to Japan's PMDA! 🇯🇵

P21 has spent many months developing this Engine with and for the PMDA, and now the industry—whether as users of P21 Community (P21C) or clients of P21 Enterprise (P21E)—can utilize it for expanded standards support, e.g., ADaMIG 1.1, in their eData submissions to the Japanese health agency.

• As of 2021-Q4, this new Engine has been successfully deployed to production at the PMDA, who announced details recently via their industry working group and public website (Japanese and English – see section on Data Standards Catalog and CDISC Data Validation).
• Now that the PMDA has made the announcement public, P21 has delivered this Engine to our user base. It is valid for use with submissions from January 1, 2022.

Key details are as follows:

• Health Agency: Japan's Pharmaceuticals and Medical Devices Agency
• Engine Name: PMDA 2010.2
• Alias: PMDA Rules Version 3.0
• Validity: Initial submissions from January 1, 2022 onward
• Platform Compatibility: P21C 3.0.0+, P21E 4.0.0+
• Documentation: PMDA’s Change Log, P21C Help > Show Engine Changelog, P21E Help Center > Announcements

Availability & Compatibility

This is an additive Engine release. That is, no former PMDA Engines are "lost" or removed from the list. When you log in to P21 Community 3.0.0 and higher online with your PinnacleID, you will see the new PMDA Engine 2010.2 present as an option in the Validator. In P21 Enterprise 4.0.0 and higher, it is present on each Data Package Configuration page.

• Former PMDA Engines are still available with the (Legacy) label. So you now have a total of three options: PMDA 2010.2, PMDA 1810.3 (Legacy), PMDA 1511.6 (Legacy).
• Our Downloads page lists in the Compatibility section the key dates for each. If you are a P21E client, our Validation History features let you revalidate datasets from PMDA 1810.3 (Legacy) to PMDA 2010.2 and automatically compare/reconcile any differences.
• P21's default stance is to promote "the latest and greatest" standards, Engines, and best practices. However, defer to your team's agreements with PMDA reviewers if a specific Engine has been agreed upon for a given in-progress submission.

Security Note: If you haven’t done so already, we strongly advise you to upgrade via our Downloads page to P21C 3.1.2, which does not contain the log4j library, the java package of concern in the recent server-side RCE exploits.

• P21C 2.2.0 and lower did use log4j. However, we have not distributed that version since May 2019. Also, End of Life for P21C 2.x and lower occurred on March 31, 2021. P21C 3.0.0 and higher do not use log4j.
• P21E does not use log4j either. P21E clients are thus unaffected, and welcome to contact our Customer Success/Support teams for details.

Guidance & Best Practices

In 2021-Q1, we plan to host an education webinar featuring our Subject Matter Experts (SMEs) in PMDA submissions. Join our mailing list to receive your invitation.

The time/date are yet to be decided, but we’re considering hosting in in multiple time zones, and perhaps separate sessions for English and Japanese language attendees.

P21C users can discuss with us and other peers in the relevant forum thread. And, as always, P21E clients are welcome to contact our Customer Success/Support teams to ask questions or arrange consultations with our SMEs.