andyzhuang/skills/labclaw/general/regulatory-submission

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