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.