Enquiry
eCTD Submission Portal body{ font-family: Arial, sans-serif; background:#f4f6f9; } .ectd-container{ max-width:1200px; margin:auto; background:white; padding:30px; border-radius:8px; box-shadow:0 0 15px rgba(0,0,0,0.08); } h2{ background:#002b5c; color:white; padding:10px; border-radius:4px; } .section{ margin-bottom:25px; padding:15px; border:1px solid #ddd; border-radius:6px; } label{ font-weight:bold; } input, select, textarea{ width:100%; padding:8px; margin-top:5px; margin-bottom:15px; border:1px solid #ccc; border-radius:4px; } button{ background:#002b5c; color:white; padding:12px 20px; border:none; border-radius:4px; cursor:pointer; } button:hover{ background:#004080; } .module-box{ background:#f9fafc; padding:15px; border-radius:6px; margin-bottom:20px; }

Enterprise eCTD Submission System

Submission Metadata

Application Number Sequence Number Submission Type Original Amendment Variation Renewal Region US – FDA EU – EMA India – CDSCO Japan – PMDA China – NMPA Korea – MFDS Applicant Name Product Name Dosage Form Strength Route of Administration Indication

Lifecycle Management

Lifecycle Operation New Replace Delete Append Related Sequence Number Reason for Change

Module 1 – Administrative Information

Cover Letter (PDF) Application Form Labeling / PI

Module 2 – Summaries

Quality Overall Summary Clinical Overview Nonclinical Overview

Module 3 – Quality

Drug Substance Specifications Drug Product Specifications Stability Data

Module 4 – Nonclinical Reports

Toxicology Reports Pharmacology Reports

Module 5 – Clinical Reports

Clinical Study Reports Bioequivalence Studies

Publishing & XML Settings

XML Backbone Version 3.2.2 4.0 Granularity Level Section Subsection Leaf Checksum Validation MD5 SHA-256