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Regulatory Submission — FDA/EMA Dossier Structure
Overview
Prepare regulatory submissions for drugs, biologics, devices, and diagnostics.
Common Submission Types
FDA (United States)
| Type | Purpose | Key Sections | |
|---|---|---|---|
| IND | Investigational New Drug | Chemistry, pharmacology, toxicology, clinical protocol | |
| NDA | New Drug Application | Full CMC, nonclinical, clinical data | |
| BLA | Biologics License | Manufacturing, characterization, clinical | |
| 510(k) | Device clearance | Substantial equivalence, performance testing | |
| PMA | Device approval | Clinical data, manufacturing | |
| EUA | Emergency use | Available data, benefit-risk |
EMA (European Union)
| Type | Purpose | |
|---|---|---|
| CTA | Clinical Trial Application | |
| MAA | Marketing Authorization Application | |
| Scientific Advice | Pre-submission guidance |
CTD Format (Common Technical Document)
Module 1: Administrative
- Cover letters, application forms, labeling
Module 2: Summaries
- 2.1 CTD table of contents
- 2.2 CTD introduction
- 2.3 Quality overall summary
- 2.4 Nonclinical overview
- 2.5 Clinical overview
- 2.6 Nonclinical written summaries
- 2.7 Clinical summaries
Module 3: Quality (CMC)
- Drug substance, drug product, manufacturing, controls
Module 4: Nonclinical
- Pharmacology, pharmacokinetics, toxicology
Module 5: Clinical
- Clinical study reports, literature references
Key Principles
- Follow ICH guidelines (ICH E6 GCP, ICH Q1-Q12)
- Data integrity: ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate)
- Risk-based approach: prioritize critical quality attributes
- Lifecycle management: post-approval changes and variations