publicCenter for Drug Evaluation (CDE), National Medical Products Administration (NMPA) · China · Updated Jul 14, 2026
Technical Guidelines for Communication on Real-World Evidence Supporting the Extension of Pediatric Indications for Marketed Drugs (Draft for Comments)
Sponsors must implement early communication strategies with the CDE regarding RWE study plans as a prerequisite for pediatric indication extension submissions.
Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Consultation
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