New Products Approved
published on 2023-09-19
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Additional Indications Approved
published on 2023-09-19
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Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2022
published on 2023-09-08
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Cephalosporins: Risk of Seizures
published on 2023-09-05
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Valaciclovir: Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
published on 2023-08-23
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List of Renewal Approved Veterinary Products
published on 2023-08-17
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Biosimilar Approved
published on 2023-08-14
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[Updated] Clindamycin (Systemic): Risk of Acute Kidney Injury
published on 2023-08-07
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Orphan Medicines Approved
published on 2023-08-04
|
Third-Generation Aromatase Inhibitors (Anastrozole; Exemestane; Letrozole): Tendon Disorders
published on 2023-08-02
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Makluman Pengemaskinian Tempoh Jangka Hayat Vaksin COVID-19 iaitu Comirnaty Kepada 24 Bulan
published on 2023-08-01
|
Screening Checklist for Generic Medicines (Prescription-Full)
published on 2023-07-31
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Makluman Pengemaskinian Tempoh Jangka Hayat Vaksin COVID-19 iaitu CoronaVac Daripada 24 Bulan Kepada 30 Bulan
published on 2023-07-31
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Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Fifth Revision July 2023
published on 2023-07-26
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Statins: Risk of Inducing or Aggravating Myasthenia Gravis
published on 2023-07-18
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Direktif untuk semua produk yang mengandungi clindamycin bagi kegunaan sistemik (sediaan oral dan injeksi) : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko Acute Kidney Injury (AKI)
published on 2023-07-13
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Kenyataan Media KPK 8 Julai 2023 - Keputusan Mesyuarat Pihak Berkuasa Kawalan Dadah Kali Ke-386 Berkenaan Kelulusan Pendaftaran Pertama Bagi Produk Semulajadi Dengan Tuntutan Terapeutik
published on 2023-07-12
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GUIDELINE ON APPLICATION OF MANUFACTURER’S, IMPORT AND WHOLESALER’S LICENSES FOR REGISTERED PRODUCTS
published on 2023-07-12
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Pekeliling Berkenaan Kawalan Impuriti Nitrosamines Dalam Produk Farmaseutikal
published on 2023-07-07
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PEKELILING Bil 2 2023 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAMAN
published on 2023-07-04
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Makluman Pengemaskinian Tempoh Jangka Hayat Antiviral COVID-19 iaitu EVUSHELD Daripada 18 Bulan Kepada 24 Bulan
published on 2023-06-26
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Direktif Berkenaan Penambahan Pernyataan Amaran Bagi Produk Suplemen Kesihatan yang Mengandungi Bahan Aktif Chromium
published on 2023-06-20
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Terlipressin (Glypressin®): Serious or Fatal Respiratory Failure and Sepsis/Septic Shock in Patients with Type 1 Hepatorenal Syndrome (Type 1 HRS)
published on 2023-06-13
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Keperluan Ujian Deoxyribonucleic Acid (DNA) Ke Atas Produk Akhir Bagi Produk Biologik Yang Menggunakan Bahan Bersumberkan Haiwan Dalam Proses Pengilangan Produk
published on 2023-05-25
|
Pekeliling berkenaan pengemaskinian keperluan dokumen pengesahan Amalan Perkilangan Baik (APB) ke atas pengilang dari luar negara untuk tujuan permohonan Lesen Import Percubaan Klinikal (LIPK)
published on 2023-05-15
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Griseofulvin: Risk of Severe Cutaneous Adverse Reactions (SCARs)
published on 2023-05-03
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Comirnaty Vaccine: Risk of Heavy Menstrual Bleeding
published on 2023-05-02
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Approved Clinical Trial Import License & Clinical Trial Exemption (CTX) Application
published on 2023-05-02
|
Azacitidine: Risk of Differentiation Syndrome
published on 2023-04-19
|
Direktif untuk semua produk yang mengandungi valaciclovir: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
published on 2023-04-13
|
Direktif untuk semua produk yang mengandungi azacitidine: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko differentiation syndrome (DS)
published on 2023-04-13
|
Direktif untuk semua produk yang mengandungi griseofulvin: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko Severe Cutaneous Adverse Reactions (SCARs)
published on 2023-04-13
|
Direktif berkenaan pelaksanaan Electronic Labelling (e-Labelling) ke atas produk farmaseutikal di Malaysia
published on 2023-04-13
|
Off-Label Use of Diclofenac Suppositories to Treat Fever in Children: Potential Risk of Acute Necrotising Encephalopathy of Childhood (ANEC)
published on 2023-04-11
|
An Analysis of Deficiencies Observed During On-Site Good Manufacturing Practice (GMP) Inspections of Local and Foreign Manufacturing Premise of Medicinal Registered Products in the Year 2022
published on 2023-04-04
|
NPRA Customer Satisfaction Survey
published on 2023-04-03
|
[Updated] Pholcodine: Risk of Anaphylaxis to Neuromuscular Blocking Agents (NMBAs)
published on 2023-03-23
|
Topiramate: Neurodevelopmental Disorders in Children Exposed to Topiramate During Pregnancy
published on 2023-03-16
|
Declaration of Worldwide Registration Status for Generic Medicines in QUEST System
published on 2023-03-10
|
Change of Venue for the National Regulatory Conference (NRC) 2023 to M Resort & Hotel, Kuala Lumpur
published on 2023-03-08
|
About the Drug Control Authority (DCA)
published on 2023-03-02
|
Direktif Berkenaan Penyenaraian Semua Polymyxins (Kecuali Polymyxin B dalam Bentuk Sediaan Topikal) Sebagai Bahan Terlarang dalam Produk Ubat Veterinar
published on 2023-02-13
|
MAKLUM BALAS BAHAGIAN REGULATORI FARMASI NEGARA (NPRA) BERHUBUNG ARTIKEL BERKAITAN RAWATAN COVID-19 YANG DITERBITKAN OLEH MEDIA BLOOMBERG DAN SCIENCE
published on 2023-02-08
|
Lawatan Kerja Rasmi YB Menteri Kesihatan Malaysia ke NPRA
published on 2023-01-17
|
Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Fourth Revision January 2023
published on 2023-01-17
|
Donepezil: Risk of QT Prolongation and Torsade de Pointes
published on 2023-01-16
|
PEKELILING Bil 1 2023 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAMAN
published on 2023-01-12
|
New Drug Products (NCE)
published on 2023-01-10
|
Guideline for Drug-Medical Device and Medical Device-Drug Combination Products, 5th Edition, 2023
published on 2023-01-09
|
DCA News
published on 2023-01-03
|
Pneumococcal Polysaccharide Vaccine (23-Valent): Extensive Swelling of Vaccinated Limb
published on 2022-12-20
|
Direktif untuk menerima permohonan Lesen Import Percubaan Klinikal (CTIL) dan Kebenaran Mengilang Produk Tidak Berdaftar Untuk Tujuan Percubaan Klinikal (CTX) bagi produk biologik (kecuali produk Cell And Gene Therapy) yang melibatkan kajian klinikal First-in-Human (FIH)
published on 2022-12-20
|
Direktif untuk semua produk yang mengandungi donepezil: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko QT prolongation dan Torsade de Pointes
published on 2022-12-20
|
Cosmetic Guidelines ( Annex I - VII )
published on 2022-12-09
|
Sorafenib: Risk of Thrombotic Microangiopathy (TMA)
published on 2022-12-09
|
Hydroxychloroquine and Chloroquine: Risk of Hepatic Impairment
published on 2022-12-06
|
😊 Thank you for joining #MedSafetyWeek 💊
published on 2022-11-13
|
💊 How Medication Safety Works? 👨⚕️🏥👩⚕️
published on 2022-11-11
|
😊 Hey, are you a pharmacist? 💊
published on 2022-11-11
|
💫 When you report a suspected side effect from a medicine, we learn more about it 💡
published on 2022-11-10
|
🤒 Have you ever experienced a side effect from a medicine? 😵
published on 2022-11-09
|
Direktif Berkenaan Pelaksanaan Garis Panduan Guidance on the Acceptance Criteria for Quantification by Input (QBI) of Active Ingredients Claimed on Label of Traditional Medicine and Health Supplement (TMHS) Products
published on 2022-11-09
|
🙋♂️ How Can You Help Us in Making Medicines Safer for Everyone? 🙋
published on 2022-11-08
|
Why do We Monitor the Safety of Medicines?🔎
published on 2022-11-07
|
Temporary Solution for Java Security Login Problem
published on 2022-11-07
|
#MedSafetyWeek Starts Today! 💊
published on 2022-11-07
|
Get Ready for #MedSafetyWeek!
published on 2022-11-03
|
Methadone: Risk of Hypoglycaemia
published on 2022-11-02
|
Piperacillin: Risk of Haemophagocytic Lymphohistiocytosis (HLH)
published on 2022-10-31
|
Iodinated Contrast Media: Risk of Hypothyroidism (Particularly in Newborns and Young Children)
published on 2022-10-27
|
Safety Updates on COVID-19 Vaccines: Risk of Tinnitus
published on 2022-10-20
|
Labetalol: Risk of Nipple Pain and Raynaud's Phenomenon of the Nipple
published on 2022-10-17
|
Sertraline: Risk of Microscopic Colitis
published on 2022-10-17
|
Direktif Untuk Semua Produk Yang Mengandungi Labetalol: Pengemaskinian Sisip Bungkusan Dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) Dengan Memperkukuhkan Maklumat Keselamatan Berkaitan Risiko Kesakitan Pada Puting Payudara Disebabkan Oleh Fenomena Raynaud
published on 2022-10-13
|
Direktif Untuk Semua Produk Yang Mengandungi Sertraline: Pengemaskinian Sisip Bungkusan Dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) Dengan Maklumat Keselamatan Berkaitan Risiko Microscopic Colitis
published on 2022-10-13
|
Direktif Untuk Semua Produk Yang Mengandungi Iodinated Contrast Media : Pengemaskinian Sisip Bungkusan Dengan Maklumat Keselamatan Berkaitan Hypothyroidism (Terutamanya Dalam Kalangan Bayi)
published on 2022-10-13
|
Nirmatrelvir/ Ritonavir (PAXLOVID): Risk of Anaphylaxis and Hypersensitivity Reactions
published on 2022-10-05
|
Brolucizumab (Pagenax®): Risk of Intraocular Inflammation, Including Retinal Vasculitis and/or Retinal Vascular Occlusion (Updated Recommendations to Minimise the Known Risks)
published on 2022-09-29
|
Alectinib (Alecensa®): Risk of Haemolytic Anaemia (New Warning and Precaution and Dose Modification Guidance)
published on 2022-09-28
|
Publication of Revised PIC/S Annex 1
published on 2022-09-27
|
Metformin: Risk of Vitamin B12 Deficiency
published on 2022-09-27
|
Penarikan Balik Syarat Pendaftaran Khas Bagi Vaksin COVID-19: Hanya Boleh Dijual Atau Dibekal Kepada Pihak Kerajaan Atau Pihak Yang Diberi Kebenaran Oleh Kerajaan Sahaja
published on 2022-09-02
|
Direktif Berkenaan Pengemaskinian Keperluan Standard Pematuhan APB Produk Steril Veterinar
published on 2022-08-15
|
Pekeliling Berkenaan Peluasan Skop Untuk Permohonan Variants Kepada Produk Dalam Bentuk Lozenges Di Bawah Kategori Produk Racun Berjadual Group C
published on 2022-08-12
|
Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2021
published on 2022-08-08
|
Update on Guidance Notes for Active Pharmaceutical Ingredients (API) Information for Product Registration - Version 6.1 (July 2022)
published on 2022-07-28
|
Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Third Revision July 2022
published on 2022-07-27
|
Corticosteroids (Systemic): Risk of Pheochromocytoma Crisis
published on 2022-07-19
|
Chloroquine and Hydroxychloroquine: Risk of Psychiatric Disorders
published on 2022-07-19
|
Pekeliling Berkenaan Pengemaskinian Garis Panduan Malaysian Variation Guideline for Pharmaceutical Products
published on 2022-07-18
|
Pekeliling Berkenaan Penamaan Semula Prosedur 'Do & Tell' kepada 'Tell & Do' dan Pengemaskinian Senarai Jenis Variasi Minor Variation (Prior Approval) dan Major Variation yang Dibenarkan untuk Diproses Melalui Prosedur ini untuk Produk Farmaseutikal, Suplemen Kesihatan dan Produk Semulajadi
published on 2022-07-18
|
Pelaksanaan Projek Rintis Pharmaceutical Track & Trace
published on 2022-07-18
|
Direktif untuk semua produk yang mengandungi chloroquine dan hydroxychloroquine: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) bagi memperkukuhkan maklumat keselamatan berkaitan risiko psychiatric disorders
published on 2022-07-18
|
Azathioprine: Risk of Erythema Nodosum
published on 2022-07-18
|
Direktif untuk semua produk yang mengandungi azathioprine: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko erythema nodosum dan menyelaraskan maklumat keselamatan lain berkenaan reaksi hipersensitiviti
published on 2022-07-18
|
Direktif untuk semua produk yang mengandungi kortikosteroid untuk kegunaan sistemik (sediaan oral dan injeksi): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko pheochromocytoma crisis
published on 2022-07-18
|
PEKELILING Bil.2 /2022 MAKLUMAN PENERBITAN EDISI TERKINI GARIS PANDUAN KOSMETIK
published on 2022-07-18
|
Pekeliling Berkenaan Pengemaskinian Status Kombinasi Bahan Aktif Corticosteroids + Antihistamines Dalam Drug Registration Guidance Document (DRGD)
published on 2022-07-15
|
Pekeliling Bil.1/2022 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAMAN
published on 2022-07-06
|
Loperamide: Risk of Acute Pancreatitis
published on 2022-06-23
|
