Module 1

Module 1: Administrative Information and Prescribing Information

Module 1 contains documents that are specific to each region. It includes administrative information such as application forms, prescribing information, and labeling. This module is NOT part of the Common Technical Document (CTD) and varies by regulatory region.

Sections

1.1 — Table of Contents

Complete table of contents for the submission

3 sub

1.2 — Cover Letter

Cover letter identifying the IND submission type, serial number, and key information

7 sub

1.3 — Administrative Information

Administrative information including contact details, certifications, and financial disclosures

5 sub

1.4 — References

Letters of authorization, right of reference statements, and cross-references to other applications

4 sub

1.5 — Application Status

Application status requests including withdrawal, inactivation, and reactivation

3 sub

1.6 — Meetings

Meeting requests and minutes for pre-IND, pre-NDA/BLA, and Type A/B/C meetings

7 sub

1.7 — Fast Track / Special Designations

Requests for fast track, breakthrough therapy, accelerated approval, priority review, orphan drug, and pediatric designations

7 sub

1.8 — IND Safety Reports

IND safety reports (Form 3500A) and follow-up safety reports per 21 CFR 312.32

2 sub

1.9 — Annual Reports

IND annual reports per 21 CFR 312.33 summarizing study progress, safety, and manufacturing changes

1.10 — Labeling

Draft labeling and Investigator Brochure (labeling section)

2 sub

1.12 — Environmental Assessment / Categorical Exclusion

Environmental assessment or categorical exclusion claim per 21 CFR 25

1.15 — General Investigational Plan

General investigational plan including overall plan, clinical protocols, and investigator information per 21 CFR 312.23(a)(3)

3 sub

Related Sections

m2 — Module 2: Common Technical Document Summaries

Module 2 provides overviews and summaries of Modules 3, 4, and 5. It includes the Quality Overall Summary, Nonclinical Overview, Clinical Overview, and detailed written/tabulated summaries.

m3 — Module 3: Quality

Module 3 contains the Body of Data for drug substance (S) and drug product (P) quality information, including manufacturing, controls, characterization, and stability per ICH M4Q guidelines.

m4 — Module 4: Nonclinical Study Reports

Module 4 contains nonclinical study reports organized per ICH M4S: pharmacology (primary, secondary, safety), pharmacokinetics (ADME), and toxicology (general, genetic, carcinogenicity, reproductive).

m5 — Module 5: Clinical Study Reports

Module 5 contains clinical study reports organized per ICH M4E: biopharmaceutic studies, human PK/PD studies, efficacy and safety studies, post-marketing data, and case report forms.

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