On Friday, September 27th, the Japanese Pharmaceutical and Medical Devices Agency (PMDA) published its long-awaited update to validation rules for SDTM, ADAM and Define.xml. PMDA Validation Rules 2.0 introduce additional standard conformance rules from CDISC, support for analysis result metadata (ARM), and many other changes.  At Pinnacle 21, we've got you covered.

We recently published a new PMDA engine to our Community tool called "PMDA (1810.3)".  With this update, we also added "Legacy" to the name of PMDA engine 1511.6.  What does Legacy mean exactly?

PMDA Legacy (1511.6) is our engine that supports PMDA Validation Rules 1.0 (released 2015-11-18).  This engine is valid for use with all applications from October 1st, 2016 through March 31, 2021.  PMDA (1810.3) is our engine that supports PMDA Validation Rules 2.0 (released 2019-09-27).  This engine is valid for use with applications after April 1st, 2020.

Read our blog post to learn more about FDA- and PMDA-specific validation engines, or click here to learn more about engine compatibility within Pinnacle 21 Community.

For any additional questions, please post on the P21 Community Forum.