📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.
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.
What it is. A summary of the Korean clinical-trial application (IND) filed with the MFDS (Ministry of Food and Drug Safety).
Why it exists. Korea requires MFDS approval of the trial plan before a clinical study may start. This document is the Korean-language administrative and scientific summary supporting that approval.
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. 약사법 / 의약품 임상시험 계획 승인(IND) 규정
| Field | Value |
|---|---|
| Document ID | IND-KR |
| Version | 1.0 |
| Region | MFDS (Korea) |
| Standard | 약사법 / 의약품 임상시험 계획 승인(IND) 규정 |
| Confidentiality | Confidential — portfolio use |
국내 임상시험 실시를 위한 임상시험계획승인(IND) 신청 요약. 행정 식별자는
[MOCK].
| Version | Date | Author | Summary |
|---|
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| 1.0 | 2026-06-29 | 한국 RA | 초판 |
중대 이상약물반응(SUSAR) 신속보고 및 정기보고를 약사법령에 따라 수행하며, 안전성 관리 계획(TMF-SMP) 및 위해성 관리 계획(RMP-KR)과 연계한다.