|
Document |
MS Word | Updated | |
|---|---|---|---|
| Checklist for submission of section P9 (Quest 3+ system) | |||
|
Application For Biopharmaceutics Classification System (BCS) Biowaiver |
Download | Download | Aug-2024 |
|
Application For A Biowaiver: Additional Strength |
Download | Download | Dec-2021 |
|
Bioequivalence Study Report Submission Checklist |
Download | Download | Aug-2024 |
|
Guide on How to Upload the BE Study Report and Other Relevant Documents in QUEST 3+ System Under Section P9 |
Download | - | Dec-2021 |
| Application form for BE centre & EC inspection | |||
|
N3-FR-42 Borang Permohonan Pemeriksaan Pusat Kajian Bioekuivalens Dalam Negara |
- | Download | Jan-2025 |
|
N3-FR-43 Borang Permohonan Pemeriksaan untuk Program Komplians NPRA bagi Pusat Kajian Bioekuivalens (Luar Negara) |
- | Download | Jan-2025 |
|
N3-FR-46 Borang Permohonan Pendaftaran Dan Pemeriksaan Jawatankuasa Etika |
- | Download | Jan-2025 |
|
N3-FR-76 Borang Laporan Tahunan Jawatankuasa Etika |
- | Download | Jan-2025 |
|
Application Form Inspection for Listing of Bioequivalence Centre ASEAN Mutual Recognition Arrangement for Bioequivalence Study Report of Generic Medicinal products. |
- | Download | May-2021 |
| Application form for evaluation on the need for BE study inspection (BEDE) | |||
|
N3-FR-80 Borang Permohonan Penilaian Penentuan Keperluan Pemeriksaan Kajian Bioekuivalens (BEDE) |
- | Download | Jan-2025 |
|
N3-FR-51 Borang L1 Maklumat Penilaian Penentuan Keperluan Pemeriksaan Kajian BE (BEDE) |
- | Download | Jan-2025 |
|
N3-FR-52 Manual Permohonan Penilaian Penentuan Keperluan Pemeriksaan Kajian Bioekuivalens (BEDE) |
Download | - | Jan-2025 |
|
N3-FR-56 BEDE Submission Checklist |
- | Download | Jan-2025 |
Application Forms and Checklist
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