PMDA SDTM Submission Requirements vs FDA: Where They Actually Diverge
StudySAS Blog | SDTM Programming | Regulatory Submissions Global teams often say, "PMDA and FDA both take SDTM, so one package should work for both." That is only half true. At the model level, the overlap is real. Both agencies expect CDISC-based submissions, SAS XPT v5 transport files, define.xml, and reviewer-facing documentation. But the real question is not whether your SDTM is CDISC-compliant. The real question is this: will the same study package survive both agencies' rule engines, review workflows, and local review habits without late rework? For teams that build for FDA first, the answer is often no, at least not without adjustment. The differences that matter most are not random. They cluster around standards catalog timing, PMDA pre-submission consultation, Japanese text handling, clinical pharmacology traceability, validation behavior, and Japanese date and time conventions. ...