📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.

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Mock / simulation document

This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.

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About this document — a plain-language guide

What it is. The index and cover layer of CTD Module 1 — the region-specific administrative forms, certifications, and references that sit in front of the scientific dossier.

Why it exists. Every submission needs an administrative wrapper (application forms, fee and financial-disclosure certifications, patent/exclusivity statements). Module 1 is the only CTD module that differs by country, so it is filed separately for each agency.

How it is produced here. This is a region-specific administrative document, assembled to the local filing and labeling conventions. Its operational and label content is written to stay consistent with the (simulated) clinical data.

Format & governing standard. eCTD regional (FDA/EMA/MFDS) · 21 CFR Parts 25, 54, 314

Module 1 — Administrative Documents & Certifications Index — GLPI-103

Field	Value
Document ID	M1-0
Version	1.0
Compound	GLPI-103 (GLP-1/APJ dual agonist)
Standard	eCTD regional (FDA/EMA/MFDS) · 21 CFR Parts 25, 54, 314
Confidentiality	Confidential

[MOCK] Index and status of the Module 1 administrative documents and certifications that accompany the application in each region. Region-specific cover letters and labeling are in M1-US / M1-EU / M1-KR; this index lists the administrative leaves and their state.

Change History

Version	Date	Author	Summary
1.0	2026-06-30	Regulatory Affairs	Initial administrative-documents index

1. Cover Letters

Region	Document	Status
US	Cover letter (M1-US §1.1)	Drafted
EU	Cover letter (M1-EU)	Drafted
KR	표지서한 (M1-KR)	Drafted

2. Application Forms

Region	Form	Status
US	Form FDA 356h (NDA) + cover letter + certifications	Executed-style form: M1-US-356h `[MOCK]`
US	Form FDA 1571 (IND, development)	Summarized (IND-US) `[MOCK]`
EU	eAF (electronic Application Form) + cover letter	Executed-style form: M1-EU-eAF `[MOCK]`
KR	MFDS 품목허가신청서 + 표지서한	Executed-style form: M1-KR-APP `[MOCK]`

3. Financial Disclosure (21 CFR 54)

Forms FDA 3454 (certification) and FDA 3455 (disclosure) for clinical investigators are provided; no disclosable financial interests that would affect the reliability of the pivotal study are identified [MOCK].

4. Debarment Certification (FD&C Act §306(k)(1))

Certification that no debarred persons were used in the application is provided [MOCK].

5. Environmental Assessment / Categorical Exclusion (21 CFR 25)

A claim of categorical exclusion under 21 CFR 25.31 is asserted; no extraordinary circumstances are identified, so an Environmental Assessment is not required [MOCK].

6. Patent and Exclusivity Information

Patent information (FD&C Act §505(b)(1)) and any exclusivity claims are provided per 21 CFR 314.53 [MOCK].

7. User Fee Cover Sheet

PDUFA user-fee cover sheet (Form FDA 3397) and fee status are included [MOCK].

8. Field Copy Certification

Certification that the field copy of the application has been provided to the applicable district office, as required [MOCK].

9. Cross-References

Region-specific administrative and labeling content: M1-US (USPI, Medication Guide, REMS), M1-EU (SmPC, EU-RMP), M1-KR (허가사항, RMP-KR). Pharmacovigilance: DSUR-001, PSUR-001, SIGNAL-001. Agency meetings: MTG-PREIND, MTG-EOP2, MTG-PRENDA, DESIG-001.