Application Form - Clinical Trial
Application Forms for Clinical Trial
Written by Seksyen Penilaian & Keselamatan Produk Kajian · 24 February 2026
| Document Name | MS Word | Other format | Current edition | |
|---|---|---|---|---|
|
N2-FR-07/3 Borang Permohonan Lesen Import Percubaan Klinikal (CTIL) |
DOWNLOAD | DOWNLoaD | - | Dec-24 |
|
N2-FR-08/3 Borang Permohonan Kebenaran Mengilang Produk-produk Tidak Berdaftar Untuk Tujuan Percubaan Klinikal (CTX) |
DOWNLOAD | DOWNLOAD | - | Dec-24 |
|
N2-FR-09/3 Borang Permohonan Variasi CTIL CTX |
DOWNLOAD | DOWNLOAD | - | Dec-24 |
|
N2-FR-13/2 Borang Penyerahan Yuran Pemprosesan Lesen Import Percubaan Klinikal |
DOWNLOAD | DOWNLOAD | - | Dec-24 |
|
Standardised file organisation folder for CTIL/CTX application (Ver. May 2024) |
- | - | DOWNLOAD | May-24 |
|
N3-FR-27/2 CTILCTX Protocol Deviation Template |
- | - | Dec-24 | |
|
N3-FR-82 Serious Breach Report |
DOWNLOAD | DOWNLOAD | - | Dec-25 |
|
N3-FR-26/4 Permohonan Pemeriksaan Untuk Program Pemeriksaan dan Akreditasi Unit Fasa Satu NPRA |
DOWNLOAD | DOWNLOAD | - | Dec-24 |
|
Template for Declaration on Good Manufacturing Practice (GMP) Compliance for Investigational Medicinal Product (IMP) Manufacturer by Competent Person |
DOWNLOAD | DOWNLOAD | - | Feb-26 |