Circulars
KAWALAN PRODUK MENGANDUNGI BAHAN AKTIF YANG MEMPUNYAI BERBERINE SECARA SEMULAJADI
Date: 09 January 2015 Description: Click here to download the document.
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Resources
Publications and guidelines
669 publications
Guidance documents, forms, circulars and reports issued by the Authority.
Circulars
Pekeliling Pemansuhan Sistem Rayuan Pengujian Sampel (Appeal for Sample Retesting) bagi Sampel Pendaftaran Produk Tradisional yang Tidak Lulus Pengujian
Date: 19 January 2015 Description: Click HERE to download the full document.
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Circulars
Pertukaran Sistem Pendaftaran Produk Daripada QUEST 3 Kepada QUEST 2 Bagi Kategori Produk TRADISIONAL Versi 2.0
Date: 04 February 2015 Description: Pengguna Sistem Quest, mulai 1hb April 2014, semua permohonan baru pendaftaran produk Tradisional akan menggunakan Sistem QUEST2. Produk-produk Tradisional yang…
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Circulars
LARANGAN PENGGUNAAN UBI GADONG (DIOSCOREA HISPIDA) DALAM PRODUK UBAT YANG DIAMBIL SECARA ORAL
Date: 17 March 2015 Description: Click here to download the document.
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Circulars
Pekeliling Larangan Penggunaan Nama Produk Yang Memberikan Imej Tradisional Untuk Produk Farmaseutikal Bukan Racun Berjadual Yang Mengandungi Bahan Aktif Sintetik Dalam Bentuk Sediaan Oral
Date: 21 May 2015 Description: Click here to download the document.
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Circulars
Pekeliling Permohonan Pendaftaran Semula Produk Quest 3 Melalui Prosedu Manual
Date: 29 May 2015 Description: Click here to download the full document
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Uncategorised
Laboratory & Quality Control
Guidelines for Protocol Analysis Checklist Checklist for Chemical Checklist for Bacteria Endotoxin Test (BET) Checklist for Sterility Test Checklist for Microbial Contamination Test (MCT) Checklist…
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Uncategorised
Active Pharmaceutical Ingredient (API)
INTRODUCTION API FAQS A significant part of the quality of a finished product is dependent on the quality of the Active Pharmaceutical ingredients (APIs) used for its formulation. Thus, a proper…
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Regulation Basic
Data Exclusivity
Data exclusivity refers to protection of undisclosed, unpublished and non-public domain pharmaceutical test data, the origination of which involves a considerable effort, submitted as required to the…
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FAQ
FAQ: Good Clinical Practice (GCP) & Good Laboratory Practice (GLP)
Document Name Updated FAQ: Good Laboratory Practice (GLP) 27 Nov 2025 FAQ: Good Clinical Practice (GCP) 1 Dec 2025
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Directives
Direktif untuk semua produk domperidone bagi mengehadkan penggunaan berikutan risiko kesan advers jantung
Date : 03 June 2015 Description : Click here to download the document.
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Directives
Direktif untuk produk yang mengandungi paracetamol, termasuk produk kombinasi : Pengemaskinian label, sisip bungkusan, dan risalah maklumat ubat untuk pengguna (RiMUP) dengan amaran berkaitan kesan advers serius pada kulit
Date: 03 June 2015 Description : Click here to download the document.
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Uncategorised
Good Laboratory Practice (GLP) Compliance Monitoring Programme
The Malaysian GLP Monitoring Authority OECD GLP Documents | Directive | Application Procedures & Application Form | FAQ NPCB GLP Compliance Programme Manual | GLP Compliant Test Facilities Good…
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Healthcare Professional
Cutaneous Adverse Drug Reaction (ADR) Classification
Clinical Manifestation of Cutaneous ADR | Glossary and Pictures of Clinical Manifestation of Cutaneous ADR
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About NPCB
DCA News
DCA News Document Name DCA-News-2025 DCA-News-2024 DCA-News-2023 DCA-News-2022 DCA-News-2021 DCA-News-2020 DCA-News-2019 DCA-News-2018 DCA-News-2017 DCA-News-2016 DCA-News-2015 DCA-News-2014…
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About NPCB
OECD-GLP-MAD
Malaysian Compliance Monitoring Authority for OECD GLP The primary objective of the OECD Principles of Good Laboratory Practice (GLP) is to ensure the generation of high quality and reliable test…
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About NPCB
WHO Collaborating Centre for Regulatory Control of Pharmaceuticals
BACKGROUND The National Pharmaceutical Regulatory Agency (NPRA) is an institution established by the Ministry of Health Malaysia in 1978. It is a regulatory agency charged with the responsibility of…
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About NPCB
Clients Charter
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About NPCB
Organisation Chart
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