Pinnacle 21 is happy to announce the latest Validation Engines for submissions to Japan PMDA, US FDA, and China NMPA!

P21 has invested much in developing these engines for/with regulatory agencies, and now the industry—whether as users of P21 Community (P21C) or clients of P21 Enterprise (P21E)—can utilize them for expanded standards support, e.g., the first time PMDA has implemented ADaMIG 1.2 & 1.3 and Define-XML 2.1, in their eData submissions to the the global regulatory bodies.

Key details are as follows:

PMDA 2311.0 - updated 17-Apr-2024

• Added initial support for ADaMIG 1.2 & 1.3
• Added initial support for Define-XML 2.1

FDA 2304.3 - updated 07-Mar-2024

• Added initial support for SDTMIG 3.4; Retired support for SDTMIG 3.1.2 & 3.1.3
• Added initial support for ADaMIG 1.2 & 1.3; Retired support for ADaMIG 1.0
• Added initial support for SENDIG-GENETOX 1.0; Retired support for SENDIG 3.0

NMPA 2304.3 - updated 07-Mar-2024

• Added initial support for SDTMIG 3.3; Retired support for SDTMIG 3.1.3

Below is a summary table of the changes, and which Engine or object they apply to. In some cases, e.g., modifications to Messages, the count will appear high, due to a large amount of grammar/phrasing harmonization that do not affect the substance of the Rule. In other cases, the count will appear low or zero, e.g., in cases where we update a wildcard or placeholder character globally across all Rules.

Availability & Compatibility

This is an additive Engine release for the PMDA. That is, no former PMDA Engines are "lost" or removed from the list; instead you will see “demotion,” e.g., of the former PMDA Engine to (Legacy) status. Similar demotions happen to FDA and NMPA, with the FDA/NMPA 2010.1 Engines being sunset entirely.

When you log in to P21 Community 3.0.0 and higher online with your PinnacleID, you will see the new Engines present as options in the Validator. In P21 Enterprise, options are present on each Data Package Configuration page.

• Our Downloads page lists in the Compatibility section the key dates for each. If you are a P21 Enterprise client, our Validation History features let you revalidate datasets from Engines/versions 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 agency reviewers if a specific Engine has been agreed upon for a given in-progress submission.

Guidance & Best Practices

In 2024-Q2, we plan to host multiple education webinars featuring our Subject Matter Experts (SMEs) in Define-XML 2.1, PMDA Submissions, and Real World Data. 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.