More Source Data Required For NMPA Clinical Trial Data Submission

On Nov 25, 2021, NMPA published two guidelines on clinical data submission requirement for medical device and IVD registration.

As per BradyKnows experiences, when the applicants choose the clinical trial pathway for China registration or include overseas clinical trial data for submission (either in clinical pathway or CER pathway), the submitted documents include each version of protocol, EC approval, SAR and CSR etc. But as per the two new guidelines, NMPA encourages the submission of clinical trial data as per Clinical Data Interchange Standards Consortium (CDISC). More source data will be submitted, including original database, analysis database, program code and explanation documents.

BradyKnows held a tailor-made workshop for global Top 3 ophthalmology manufacturer recently, covering the topics on China GCP, clinical trial operation and NMPA onsite inspection. Please reach out to us via info@inspirativemed for a tailor-made workshop and any questions about China entry.