10 Small Submissions
No more than 10 Documents per submission
Country: The USA
Health Authority: US Food & Drug Administration (USFDA)
eCTD, Accepted Since: May 5, 2017
eCTD Version: Module 1 Specification v2.5 and DTD v3.3, M2-M5 – v3.2.2 and v4.0
IND, NDA, ANDA, BLA, DMF, Structured Product Labeling (SPL) Submissions, Originals, Amendments, Annual report Submissions, Labeling Supplement Submissions, Periodic Adverse Drug Experience Report (PADERS), eCTD baseline Submissions, eCTD Submissions for lifecycle management (LCM)
Electronic submission of standardized study data for NDA, BLA, ANDA,
and Commercial IND - September 15, 2021
EU, Health Canada, Switzerland, South Africa, Australia, EAEU, Jordan, Thailand, GCC, ASEAN