Recent Updates for Industries

Kadar pengguna: 4 / 5

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Additional Indications Approved
published on 2024-04-06


New Products Approved
published on 2024-04-06


Makluman Penambahbaikan Proses Pengeluaran Lesen Mengimport / Lesen Pemborong melalui Penilaian dan Pemeriksaan Pra-Pelesenan
published on 2024-04-05


Information Sharing Paper for Cosmetic Products in the 37th ASEAN Cosmetic Committee Meeting (8-9th May 2023)
published on 2024-03-27


Guidelines for Clinical Trial
published on 2024-03-20


Direktif Berkenaan Pengemaskinian Garis Panduan Malaysian Guideline For Application Of Clinical Trial Import Licence (CTIL) And Clinical Trial Exemption (CTX)
published on 2024-03-19


Orphan Medicines Approved
published on 2024-03-14


Domperidone: Risk of Psychiatric Withdrawal Events When Used Off-Label for Lactation Stimulation
published on 2024-03-12


Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2023
published on 2024-03-11


[Updated] Metformin: Risk of Vitamin B12 Deficiency
published on 2024-03-04


Biosimilar Approved
published on 2024-02-23


Direktif berkenaan pindaan kepada proses meluluskan permohonan Lesen Import Percubaan Klinikal (CTIL) dan Kebenaran Untuk Mengilang Produk Tidak Berdaftar Untuk Tujuan Percubaan Klinikal (CTX) yang melibatkan kajian klinikal First-in-Human (FIH).
published on 2024-02-20


Direktif Berkenaan Pengemaskinian dan Pelaksanaan Guideline for Facilitated Registration Pathway (FRP), Revision 1, 2023
published on 2024-02-19


Pekeliling Berkenaan Pengemaskinian Guidance Document and Guidelines for Registration of Biosimilars in Malaysia
published on 2024-02-19


Guidance Document and Guidelines for Registration of Biosimilars in Malaysia
published on 2024-02-19


Guideline For Facilitated Registration Pathway
published on 2024-02-17


Statins (Atorvastatin, Rosuvastatin, Simvastatin): Interaction with Ticagrelor Leading to Increased Risk of Rhabdomyolysis
published on 2024-02-15


Keputusan Mesyuarat Pihak Berkuasa Kawalan Dadah Kali Ke-393
published on 2024-02-09


Rejection of BE Studies Conducted at the BE Centre Synapse Labs Pvt. Ltd., India following Inspection Findings by The European Medicines Agency (EMA)
published on 2024-01-23


Makluman Pengemaskinian Tempoh Jangka Hayat Vaksin COVID-19 iaitu CoronaVac Daripada 30 Bulan Kepada 36 Bulan
published on 2024-01-23


Penolakan Kajian Bioekuivalens (BE) yang Dijalankan oleh Pusat Kajian BE Synapse Labs Pvt. Ltd. Susulan Penemuan Pemeriksaan European Medicines Agency (EMA)
published on 2024-01-23


Imatinib: Risk of Thrombotic Microangiopathy
published on 2024-01-22


PEKELILING BIL 1/2024 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA
published on 2024-01-19


Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Seventh Revision January 2024
published on 2024-01-19


Rivastigmine: Risks of QT Prolongation and Torsade de Pointes
published on 2024-01-19


Pekeliling berkenaan pengemaskinian syarat pendaftaran midazolam dalam Drug Registration Guidance Document (DRGD)
published on 2024-01-18


Direktif untuk semua produk yang mengandungi rivastigmine: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) dengan maklumat keselamatan berkaitan risiko QT prolongation dan Torsade de Pointes (TdP)
published on 2024-01-18


Direktif untuk semua produk yang mengandungi imatinib: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) dengan maklumat keselamatan berkaitan risiko thrombotic microangiopathy (TMA)
published on 2024-01-18


Direktif untuk semua produk yang mengandungi metformin (termasuk produk kombinasi): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) bagi memperkukuhkan maklumat keselamatan berkaitan risiko kekurangan vitamin B12 (vitamin B12 deficiency)
published on 2024-01-17


New Drug Products (NCE)
published on 2023-12-26


List of Renewal Approved Veterinary Products
published on 2023-12-21


DCA News
published on 2023-12-20


Pekeliling Berkenaan Pengemaskinian Guidance Document and Guidelines for Registration of Biosimilars in Malaysia
published on 2023-12-18


Clomiphene: Risk of Serious Visual Disturbances Potentially Leading to Blindness
published on 2023-12-01


Ibrutinib (IMBRUVICA®): Package Insert Updates to Dose Modifications for Adverse Reactions and to Special Warnings and Precautions for Use
published on 2023-11-29


[Updated] Loperamide: Risk of Acute Pancreatitis
published on 2023-11-29


[Updated] Topiramate: Neurodevelopmental Disorders in Children Exposed to Topiramate during Pregnancy
published on 2023-11-28


Thanks for Joining #MedSafetyWeek 2023 💖
published on 2023-11-11


Hi! Are You a Nurse? 🏥
published on 2023-11-10


Approved Clinical Trial Import License & Clinical Trial Exemption (CTX) Application
published on 2023-11-10


Hey, Are You a Doctor? 👨‍⚕️🏥👩‍⚕️
published on 2023-11-09


Concerned About Side Effects? Remember to check 👀 , talk 🗣 , and tell 💬 this #MedSafetyWeek!
published on 2023-11-08


💊 Medications in Malaysia are Continually Monitored to Ensure Their Safety 🔎
published on 2023-11-07


Sleep Troubles After Medication 😵? Remember to Report Them 📝
published on 2023-11-06


Unexpected Side Effects Can Happen Anywhere, at Any Time: Your Report, Patients' Safety 💊
published on 2023-11-06


📣 #MedSafetyWeek kicks off today!
published on 2023-11-05


Preparations for #MedSafetyWeek are well underway – are you ready?
published on 2023-11-03


Get Ready for #MedSafetyWeek 2023!
published on 2023-11-01


Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Sixth Revision October 2023
published on 2023-10-24


Isotretinoin: Risk of Psychiatric Disorders and Sexual Dysfunction
published on 2023-10-13


Direktif untuk semua produk yang mengandungi topiramate: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko gangguan neurodevelopmental dalam kalangan kanak-kanak yang terdedah kepada topiramate semasa kehamilan ibu dan menyelaraskan maklumat keselamatan berkenaan risiko kecacatan kongenital (congenital malformation)
published on 2023-10-13


Direktif untuk semua produk yang mengandungi loperamide : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko pankreatitis akut (acute pancreatitis)
published on 2023-10-13


Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2022
published on 2023-09-08


Cephalosporins: Risk of Seizures
published on 2023-09-05


Valaciclovir: Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
published on 2023-08-23


[Updated] Clindamycin (Systemic): Risk of Acute Kidney Injury
published on 2023-08-07


Third-Generation Aromatase Inhibitors (Anastrozole; Exemestane; Letrozole): Risk of Tendon Disorders
published on 2023-08-02


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


Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Fifth Revision July 2023
published on 2023-07-26


Statins: Risk of Inducing or Aggravating Myasthenia Gravis
published on 2023-07-18


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


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


GUIDELINE ON APPLICATION OF MANUFACTURER’S, IMPORT AND WHOLESALER’S LICENSES FOR REGISTERED PRODUCTS
published on 2023-07-12


Pekeliling Berkenaan Kawalan Impuriti Nitrosamines Dalam Produk Farmaseutikal
published on 2023-07-07


PEKELILING BIL 2/2023 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA
published on 2023-07-04


Makluman Pengemaskinian Tempoh Jangka Hayat Antiviral COVID-19 iaitu EVUSHELD Daripada 18 Bulan Kepada 24 Bulan
published on 2023-06-26


Direktif Berkenaan Penambahan Pernyataan Amaran Bagi Produk Suplemen Kesihatan yang Mengandungi Bahan Aktif Chromium
published on 2023-06-20


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


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


Griseofulvin: Risk of Severe Cutaneous Adverse Reactions (SCARs)
published on 2023-05-03


Comirnaty Vaccine: Risk of Heavy Menstrual Bleeding
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


MADRAC Members
published on 2023-03-15


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


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 DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA
published on 2023-01-12


Guideline for Drug-Medical Device and Medical Device-Drug Combination Products, 5th Edition, 2023
published on 2023-01-09


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


National Pharmaceutical Regulatory Agency (NPRA)

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