1---2name: regulatory-submission3description: Regulatory Submission — FDA/EMA Dossier Structure4---5# Regulatory Submission — FDA/EMA Dossier Structure67## Overview8Prepare regulatory submissions for drugs, biologics, devices, and diagnostics.910## Common Submission Types1112### FDA (United States)13| Type | Purpose | Key Sections |14|------|---------|-------------|15| IND | Investigational New Drug | Chemistry, pharmacology, toxicology, clinical protocol |16| NDA | New Drug Application | Full CMC, nonclinical, clinical data |17| BLA | Biologics License | Manufacturing, characterization, clinical |18| 510(k) | Device clearance | Substantial equivalence, performance testing |19| PMA | Device approval | Clinical data, manufacturing |20| EUA | Emergency use | Available data, benefit-risk |2122### EMA (European Union)23| Type | Purpose |24|------|---------|25| CTA | Clinical Trial Application |26| MAA | Marketing Authorization Application |27| Scientific Advice | Pre-submission guidance |2829## CTD Format (Common Technical Document)30### Module 1: Administrative31- Cover letters, application forms, labeling3233### Module 2: Summaries34- 2.1 CTD table of contents35- 2.2 CTD introduction36- 2.3 Quality overall summary37- 2.4 Nonclinical overview38- 2.5 Clinical overview39- 2.6 Nonclinical written summaries40- 2.7 Clinical summaries4142### Module 3: Quality (CMC)43- Drug substance, drug product, manufacturing, controls4445### Module 4: Nonclinical46- Pharmacology, pharmacokinetics, toxicology4748### Module 5: Clinical49- Clinical study reports, literature references5051## Key Principles52- Follow ICH guidelines (ICH E6 GCP, ICH Q1-Q12)53- Data integrity: ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate)54- Risk-based approach: prioritize critical quality attributes55- Lifecycle management: post-approval changes and variations
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