Module 2summaryndaind
2.1 — CTD Table of Contents
Table of contents for the CTD
Requirements by Phase
Phase 1
required
Phase 2
required
Phase 3
required
NDA
required
Table of contents for the CTD
Requirements by Phase
IND Phase 1: required IND Phase 2: required IND Phase 3: required NDA: required
Content Requirements
- Complete table of contents for Modules 2 through 5
- Document titles and locations within the CTD structure
- For paper CTD: paginated TOC; for eCTD: structure serves as TOC
Expected Deliverables
- Paginated table of contents
ICH Guidelines: ICH M4
Source: ICH M4
References
Related Sections
Up toModule 2: Common Technical Document Summaries2.2 — CTD Introduction
Brief introduction to the drug including pharmacological class and proposed indication
2.3 — Quality Overall Summary
Quality overall summary covering drug substance and drug product (40-80 pages for NDA)
2.4 — Nonclinical Overview
Nonclinical overview: integrated assessment of pharmacology, PK, and toxicology (~30 pages for NDA)
2.5 — Clinical Overview
Clinical overview: benefit-risk analysis based on all clinical data (~30 pages for NDA)
2.6 — Nonclinical Written and Tabulated Summaries
Nonclinical written and tabulated summaries covering pharmacology, PK, and toxicology (100-150 pages for NDA)
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