1---2name: regulatory-submission3description: Regulatory Submission — FDA/EMA Dossier Structure4---56# Regulatory Submission — FDA/EMA Dossier Structure78## Overview9Prepare regulatory submissions for drugs, biologics, devices, and diagnostics.1011## Common Submission Types1213### FDA (United States)14| Type | Purpose | Key Sections |15|------|---------|-------------|16| IND | Investigational New Drug | Chemistry, pharmacology, toxicology, clinical protocol |17| NDA | New Drug Application | Full CMC, nonclinical, clinical data |18| BLA | Biologics License | Manufacturing, characterization, clinical |19| 510(k) | Device clearance | Substantial equivalence, performance testing |20| PMA | Device approval | Clinical data, manufacturing |21| EUA | Emergency use | Available data, benefit-risk |2223### EMA (European Union)24| Type | Purpose |25|------|---------|26| CTA | Clinical Trial Application |27| MAA | Marketing Authorization Application |28| Scientific Advice | Pre-submission guidance |2930## CTD Format (Common Technical Document)31### Module 1: Administrative32- Cover letters, application forms, labeling3334### Module 2: Summaries35- 2.1 CTD table of contents36- 2.2 CTD introduction37- 2.3 Quality overall summary38- 2.4 Nonclinical overview39- 2.5 Clinical overview40- 2.6 Nonclinical written summaries41- 2.7 Clinical summaries4243### Module 3: Quality (CMC)44- Drug substance, drug product, manufacturing, controls4546### Module 4: Nonclinical47- Pharmacology, pharmacokinetics, toxicology4849### Module 5: Clinical50- Clinical study reports, literature references5152## Key Principles53- Follow ICH guidelines (ICH E6 GCP, ICH Q1-Q12)54- Data integrity: ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate)55- Risk-based approach: prioritize critical quality attributes56- Lifecycle management: post-approval changes and variations