π New Engines: P21 & FDA
Pinnacle 21 announces the latest Validation Engine for submissions to US FDA and for use as the agency-agnostic "superset" P21 Engine. This update includes several algorithm changes, message updates, new BIMO rules, and resolves bugs discovered in the previous engines P21 2405.0 and FDA 2405.0.
P21E clients on P21E 5.4.x and higher can now utilize this engine update for expanded standards support and validation rule enhancements.
Note: NMPA will release Engine 2405.x in a separate, standalone Engine update, but this is not yet available.
The new Engines will be deployed to your environment automatically, so there is no need for any action on your part. Once deployed, Data Package Configuration page will list a total of 8 Engines:
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π Deployment Impact
For the FDA Engine, we respect your prior Configuration settings. Meaning, for Data Package with Configurations set to FDA 2304.3, after the release of FDA 2405.1, those Configurations will remain as FDA 2304.3 (Legacy). So, to use FDA 2405.1 for those Data Packages, you need to manually reconfigure them to FDA 2405.1. If a Data Package was configured to FDA 2405.0 prior to this patch release, the Data Package configuration will automatically update to FDA 2405.1.
For the P21 and NMPA Engines, there is no "Legacy" concept. So prior Configuration settings of the P21 Engine will, after the release of P21 2405.1, be updated to P21 2405.1.
In this Engine release, PMDA Engines are unaffected in substance, having been updated independently long beforehand.
π§ Technical Details
On the Data Package Configuration page, click the radio button for each Engine to see instructional notes, applicable dates, etc., pasted below for reference:
P21 2405.1 - Last updated: 2024-09-14 Has the latest official FDA, PMDA, and NMPA rules. When FDA and PMDA have different algorithms for a rule, the latest one prevails. This Engine has rules for custom standards and CT.
FDA 2405.1 - Last updated: 2024-09-14. Only this Engine is currently deployed at FDA. It is identical to the P21 Engine but excludes PMDA and NMPA rules.
PMDA 2311.0 - Last updated: 2024-04-01 This Engine is currently deployed at PMDA, aka "PMDA rules version 5.0." Valid for submission dates of 2023-3-31 onward.
NMPA 2304.3 β Last updated: 2024-01-05 The is the beta Engine for NMPA. Supports Chinese-language datasets and displays rule messages and descriptions in Chinese.
FDA 2304.3 (Legacy) β Last updated: 2024-01-05 This Engine was previously deployed at FDA. Do not use for current submissions.
PMDA 2211.1 (Legacy) β Last updated: 2023-12-15 This Engine was previously deployed at PMDA. Valid for initial submission dates through 2024-03-31.
PMDA 2010.2 (Legacy) β Last updated: 2021-12-15, patch #2 This is the previous Engine deployed at PMDA, aka "PMDA rules version 3.0." Valid for initial submission dates of 2022-01-01 to 2025-03-31.
PMDA 1810.3 (Legacy) β Last updated: 2019-11-20, patch #3 This is the previous Engine deployed at PMDA, aka "PMDA rules version 2.0." Valid for initial submission dates of 2020-04-01 to 2023-03-31.
P21's default stance is to promote "the latest and greatest" standards, Engines, and best practices. 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.
π£ Whatβs Next
Learn more in the Announcements collection.
Email questions or feedback to support@pinnacle21.atlassian.net.