Guidelines Related to BEEC Inspection
1) Malaysian Guideline for BE Inspection
3) Manual Permohonan Penilaian Penentuan Keperluan Pemeriksaan Kajian BE
4) Malaysian Guideline for Good Clinical Practice, 4th Edition
5) Malaysian Guideline for Good Clinical Practice (GCP) Inspection, Edition 2.1
6) Malaysian Guideline for Independent Ethics Committee Registration and Inspection, 1st Edition
- Malaysian Guideline for BE Inspection, 2nd Edition
- Malaysian Guideline for BE Inspection, 2nd Edition [draft]
- Public consultation: 8 April 2024 - 6 May 2024 [CLOSED]
- Laporan seranta awam
- Public consultation report
- Malaysian Guideline for BE Inspection, 2nd Edition [draft]
- Malaysian Guideline for BE Inspection, 1st Edition [obsolete]
3) Manual Permohonan Penilaian Penentuan Keperluan Pemeriksaan Kajian BE
4) Malaysian Guideline for Good Clinical Practice, 4th Edition
5) Malaysian Guideline for Good Clinical Practice (GCP) Inspection, Edition 2.1
6) Malaysian Guideline for Independent Ethics Committee Registration and Inspection, 1st Edition
1) Procedures and Manual of Joint Sectoral Committee (JSC) and Annexes [external link]
2) Operation Manual of the Panel of Experts (PoE) and Annexes [external link]
3) Manual for Application of Bioequivalence (BE) Centre to be listed under ASEAN MRA BE and Annexes [external link]
Original document can be accessed at: https://asean.org/our-communities/economic-community/standard-and-conformance/
> Key Documents and Publications > Policy & Guidelines > 8. Pharmaceutical Product Working Group (PPWG)
