#MedSafetyWeek 2026 starts today!
published on 2026-11-02
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We're counting down to #MedSafetyWeek 2026 – join us! ⏱️
published on 2026-10-30
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Diosmin and Diosmin-Hesperidin Combination: Increased Risk of Bleeding
published on 2026-10-27
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Biosimilar Approved
published on 2026-10-26
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Direktif untuk semua produk yang mengandungi non-vitamin K antagonist oral anticoagulants (NOACs) [dabigatran, rivaroxaban, apixaban dan edoxaban]: Pengemaskinian sisip bungkusan dan RiMUP dengan maklumat keselamatan berkaitan risiko anticoagulant-related nephropathy (ARN)
published on 2026-10-20
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Direktif untuk semua produk yang mengandungi Atorvastatin: Pengemaskinian sisip bungkusan dan RiMUP dengan maklumat keselamatan berkaitan risiko reaksi fotosensitiviti (photosensitivity reaction)
published on 2026-10-20
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New Products Approved
published on 2026-10-13
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List of Renewal Approved Veterinary Products
published on 2026-10-13
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Additional Indications Approved
published on 2026-10-13
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GLP-1 and Dual GLP-1/GIP Receptor Agonists: Risk of Intestinal Obstruction
published on 2026-10-13
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Products containing Turmeric and Curcuminoids: Risk of Hepatotoxicity
published on 2026-10-06
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Guideline on Application of Manufacturer’s License, Import License and Wholesaler’s License for Registered Products (5th Edition, September 2026)
published on 2026-09-25
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Direktif Pelaksanaan dan Pengendalian Label Keselamatan
published on 2026-09-18
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Itraconazole: Risk of Pseudoaldosteronism
published on 2026-08-26
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Approved Clinical Trial Import License (CTIL) & Clinical Trial Exemption (CTX) Application
published on 2026-08-14
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GLP-1 and Dual GLP-1/GIP Receptor Agonists: Risk of Severe Acute Pancreatitis
published on 2026-07-22
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Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, 12th Revision July 2026
published on 2026-07-16
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New Login Method for QUEST3+ System – MyTrustID
published on 2026-07-07
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Lamotrigine: Risk of Photosensitivity Reactions
published on 2026-07-06
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Cefazolin: Risk of Kounis Syndrome
published on 2026-07-06
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PEKELILING BIL 2/2026 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA
published on 2026-07-06
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Aciclovir (Oral/Injectable) and Valaciclovir: Risk of Acute Generalised Exanthematous Pustulosis (AGEP)
published on 2026-07-06
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Direktif untuk semua produk yang mengandungi itraconazole: Pengemaskinian sisip bungkusan dan RiMUP bagi memperkukuhkan maklumat keselamatan berkaitan risiko pseudoaldosteronism
published on 2026-06-19
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Direktif untuk semua produk yang mengandungi vancomycin: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko toxic epidermal necrolysis (TEN) serta penyeragaman maklumat keselamatan produk berkaitan severe cutaneous adverse reactions (SCARs)
published on 2026-06-19
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Direktif Berkenaan Penambahan Pernyataan Amaran bagi Produk Suplemen Kesihatan (HS) dan Produk Bukan Racun Berjadual (OTC) yang Mengandungi Vitamin B6 Berkaitan Risiko Peripheral Neuropathy
published on 2026-06-19
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Direktif Berkenaan Pengemaskinian Had Penggunaan dan Maklumat Keselamatan bagi Caffeine dalam Produk Farmaseutikal
published on 2026-06-19
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Pekeliling Berkaitan Format Tarikh Luput pada Label Produk
published on 2026-06-12
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COLUMVI® (Glofitamab): New Important Identified Risk of Haemophagocytic Lymphohistiocytosis
published on 2026-05-25
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Directives & Circulars (GCP & GLP)
published on 2026-05-15
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Guidelines related to GCP & GLP
published on 2026-05-14
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Frequently Asked Questions (FAQ) e-labelling
published on 2026-05-13
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Pekeliling Berkenaan Pemberhentian Pengeluaran Dear Healthcare Provider (DHCP) Letter Bercetak Berserta Salinan Bercetak Package Insert (PI) dan / atau Risalah Maklumat Ubat untuk Pengguna (RiMUP) bagi Pelaksanaan Electronic Labelling (e-Labelling) ke atas Produk Farmaseutikal
published on 2026-05-13
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Clindamycin Hydrochloride (Oral Capsules): Risk of Oesophagitis and Oesophageal Ulcer
published on 2026-05-13
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New Route under the Facilitated Registration Pathway (FRP): A One-Year Pilot Study Commencing 2 May 2026
published on 2026-05-07
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Mesalazine: Risk of Idiopathic Intracranial Hypertension (IIH)
published on 2026-05-07
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Moxifloxacin: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Fixed-Drug Eruption (FDE), and Photosensitivity Associated with Systemic Use
published on 2026-04-29
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Sunitinib: Risk of Hyperammonaemic Encephalopathy
published on 2026-04-29
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Official Launch of the NPRA GCP, GLP, BE & EC Inspection Dashboard
published on 2026-04-27
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Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2025
published on 2026-04-20
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Update Of 'Borang Permohonan Sijil Indikasi / Sijil Deklarasi Bagi Produk Berdaftar Dengan Pihak Berkuasa Kawalan Dadah'
published on 2026-04-20
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Pekeliling Berkenaan Penyelarasan Keperluan Pelabelan Blister/Strip bagi Produk Semula Jadi dengan Produk Farmaseutikal dan Suplemen Kesihatan
published on 2026-04-14
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Pekeliling Pengemaskinian Drug Registration Guidance Document (DRGD) Berkenaan Nama Pemegang Pendaftaran Produk (PRH) dan/atau Pengilang Yang Menggambarkan Agensi Kerajaan dan Institusi Penyelidikan / Pengajian Tinggi
published on 2026-04-14
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Direktif untuk semua produk yang mengandungi sunitinib: Pengemaskinian sisip bungkusan dan RiMUP dengan maklumat keselamatan berkaitan risiko hyperammonaemic encephalopathy
published on 2026-04-14
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Update on Analytical Testing and Labelling Declaration Requirements for Products Containing Animal-Derived Materials
published on 2026-04-14
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Direktif untuk semua produk yang mengandungi lamotrigine: Pengemaskinian sisip bungkusan dan RiMUP bagi memperkukuhkan maklumat keselamatan berkaitan risiko fotosensitiviti (photosensitivity)
published on 2026-04-14
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CELLCEPT® (Mycophenolate mofetil): New Important Identified Risk – Anaphylactic Reaction
published on 2026-03-19
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Denosumab (Prolia®) and Biosimilars: Multi Vertebral Fractures (MVF) after Discontinuation of Denosumab – Strengthened Warnings
published on 2026-03-19
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PEKELILING BERKENAAN PENGEMASKINIAN KEPERLUAN UJIAN ANALITIKAL DAN KEPERLUAN DEKLARASI PADA LABEL BAGI SEMUA KATEGORI PRODUK YANG MENGANDUNGI BAHAN BERSUMBERKAN HAIWAN
published on 2026-03-17
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List of GLP Compliant Test Facilities
published on 2026-03-16
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Direktif Untuk Penggunaan Malaysian Guideline For Good Clinical Practice (GCP) Inspection 3rd Edition
published on 2026-03-04
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Direktif Untuk Deklarasi Personel Kompeten Amalan Perkilangan Baik (APB) bagi Produk Perubatan Penyelidikan
published on 2026-02-23
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Direktif Berkenaan Keperluan Pengujian Kandungan Diethylene Glycol (DEG) dan Ethylene Glycol (EG) ke atas Bahan Aktif / Excipient dan / atau Produk Siap dalam Bentuk Dos Cecair untuk Kegunaan Dalaman (Oral) yang Mengandungi Bahan Aktif / Excipient Berisiko
published on 2026-02-12
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Palbociclib: Risk of Venous Thromboembolism
published on 2026-02-10
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Linezolid: Risk of Rhabdomyolysis
published on 2026-02-10
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Procedures & Forms
published on 2026-02-08
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Direktif untuk Penggunaan Malaysian Guideline for Good Clinical Practice (GCP) 5th Edition
published on 2026-02-03
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Vitamin B6 (Pyridoxine): Risk of Peripheral Neuropathy
published on 2026-01-27
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Garcinia Cambogia and Hydroxycitric Acid: Risk of Hepatotoxicity
published on 2026-01-27
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PEKELILING BIL 1/2026 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA
published on 2026-01-26
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Guideline for Drug-Medical Device and Medical Device-Drug Combination Products, 5th Edition, 2024
published on 2026-01-22
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Prescription Opioid: Risk of Oesophageal Dysfunction
published on 2026-01-22
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Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, 11th Revision January 2026
published on 2026-01-21
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Direktif untuk semua produk yang mengandungi kombinasi sulfamethoxazole dan trimethoprim (cotrimoxazole): Pengemaskinian sisip bungkusan dan RiMUP dengan maklumat keselamatan berkaitan risiko circulatory shock
published on 2026-01-20
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Direktif untuk semua produk yang mengandungi clindamycin dalam sediaan oral kapsul: Pengemaskinian sisip bungkusan dan RiMUP bagi memperkukuhkan maklumat keselamatan berkaitan risiko oesophagitis dan oesophageal ulcer
published on 2026-01-20
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Direktif untuk semua produk yang mengandungi linezolid: Pengemaskinian sisip bungkusan dan RiMUP dengan maklumat keselamatan berkaitan risiko rhabdomyolysis
published on 2026-01-20
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Direktif untuk semua produk yang mengandungi palbociclib: Pengemaskinian sisip bungkusan dan RiMUP dengan maklumat keselamatan berkaitan risiko venous thromboembolism (VTE)
published on 2026-01-20
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Direktif Pelaksanaan Mekanisme Reliance dan Priority Review Bagi Permohonan Tambahan Indikasi Produk Inovator Berdaftar
published on 2026-01-20
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Pengemaskinian Drug Registration Guidance Document (DRGD) Berkaitan Permohonan Variasi Produk Berdaftar : Tempoh Masa Pemprosesan Bagi Semua Kategori Produk dan Pengenalan Mekanisme Reliance Bagi Produk Farmaseutikal
published on 2026-01-16
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Notis Pembersihan Data Produk Berstatus “SAVED FORM (EXPIRED)” dalam Sistem QUEST 3+
published on 2026-01-08
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DCA News
published on 2025-12-29
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New Drug Products (NCE)
published on 2025-12-19
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Direktif Berkenaan Larangan Penggunaan Mucuna pruriens Dalam Produk Semula Jadi dan Suplemen Kesihatan
published on 2025-12-17
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Application Forms for Clinical Trial
published on 2025-12-01
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FAQ: Good Clinical Practice (GCP) & Good Laboratory Practice (GLP)
published on 2025-12-01
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MAKLUMAN PENUTUPAN PEMBAYARAN AKHIR TAHUN 2025
published on 2025-11-26
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Cyclin-Dependent Kinase Inhibitors (CDKIs): Interaction with Statins Leading to Potential Risk of Rhabdomyolysis
published on 2025-11-17
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Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Risk of Persistent Sexual Dysfunction
published on 2025-11-14
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[Updated] Sulfamethoxazole, Trimethoprim (Cotrimoxazole): Risk of Circulatory Shock
published on 2025-11-14
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Amiodarone: Risk of Primary Graft Dysfunction after Heart Transplantation
published on 2025-11-14
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PEMAKLUMAN : PEMULIHAN SISTEM QUEST3+
published on 2025-11-13
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#MedSafetyWeek turns 10! 🎉
published on 2025-11-09
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That’s a wrap on this year’s #MedSafetyWeek campaign! 🎉
published on 2025-11-09
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SIARAN MEDIA KEMENTERIAN KESIHATAN MALAYSIA PELANCARAN MINGGU KESELAMATAN UBAT #MedSafetyWeek 2025
published on 2025-11-08
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Monitoring the safety of medicines doesn’t stop once they hit the pharmacy shelves
published on 2025-11-08
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4️⃣ Ways Healthcare Professionals can be #MedSafetyHeroes 💊🌍
published on 2025-11-07
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4️⃣ Ways Patients can be #MedSafetyHeroes 💊🌍
published on 2025-11-06
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Medicines safety starts with you and me 🤝
published on 2025-11-05
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Do you know how to be a #MedSafetyHero? 💪❓
published on 2025-11-04
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#MedSafetyWeek 2025 starts today! 🚀
published on 2025-11-03
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We all have the power to be a #MedSafetyHero 👦🏻👧👩🏾👨🏻👵🏼👴🤰🏻
published on 2025-11-03
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#MedSafetyWeek is almost here — Are you ready? 🙌
published on 2025-10-31
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📣 Jom sertai Majlis Pelancaran #MedSafetyWeek 2025
published on 2025-10-24
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Safety Signal Alert: Doxycycline-Fixed Drug Eruption (FDE)
published on 2025-10-13
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OBSOLETE_ Good Tissue Practice Guideline
published on 2025-10-10
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Direktif untuk semua produk yang mengandungi Selective Serotonin Reuptake Inhibitor (SSRI) dan Serotonin-Norepinephrine Reuptake Inhibitor (SNRI): Pengemaskinian sisip bungkusan dan RiMUP dengan maklumat keselamatan berkaitan risiko sexual dysfunction berterusan
published on 2025-10-09
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Direktif untuk semua produk yang mengandungi amiodarone: Pengemaskinian sisip bungkusan dan RiMUP dengan maklumat keselamatan berkaitan risiko primary graft dysfunction (PGD) selepas pemindahan jantung (heart transplantation)
published on 2025-10-09
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Direktif Berkenaan Penggunaan Label Keselamatan Farmatag® Baharu daripada Syarikat Netsmart Sdn Bhd
published on 2025-10-09
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Finasteride and Dutasteride: Risk of Suicidal Thoughts
published on 2025-09-23
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Pekeliling Berkenaan Pengemaskinian Guidance Document And Guidelines For Registration Of Cell And Gene Therapy Products (CGTPs) In Malaysia (Second Edition)
published on 2025-09-22
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Direktif untuk semua produk yang mengandungi Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists: Pengemaskinian sisip bungkusan dan RiMUP dengan maklumat keselamatan berkaitan risiko aspiration dan pneumonia aspiration semasa anestesia umum (general anaesthesia) atau sedasi penuh (deep sedation)
published on 2025-09-22
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