Recent Updates for Industries

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Hydroxychloroquine and Chloroquine: Risk of Hepatic Impairment
published on 2022-12-06


Biosimilar Approved
published on 2022-11-30


Orphan Medicines Approved
published on 2022-11-23


😊 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


New Products Approved
published on 2022-11-07


Additional Indications Approved
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


Cosmetic GMP Training 2022: Compilation and Summary of the Q&A
published on 2022-09-15


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


List of Renewal Approved Veterinary Products
published on 2022-07-14


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


Pekeliling Berkenaan Pindaan Kriteria Bagi Produk Yang Layak Memohon Pendaftaran Fast Track Bersyarat Untuk Produk Farmaseutikal Semasa Bencana
published on 2022-06-22


Empagliflozin: Risk of Tubulointerstitial Nephritis
published on 2022-06-20


Guide on How to Upload the Analytical Method Validation Report in Quest 3+ System Under Section E12 & E13
published on 2022-06-20


Olmesartan: Risk of Autoimmune Hepatitis
published on 2022-06-16


Mavenclad® (Cladribine): Risk of Serious Liver Injury and New Recommendations About Liver Function Monitoring
published on 2022-06-13


Pekeliling Berkenaan Peluasan Skop Permohonan Pertukaran Tapak Pengilang/Change Of Manufacturing Site (COS) Type III dan Type IV
published on 2022-06-10


Application Forms for Veterinary Medicine
published on 2022-05-30


Pekeliling Berkenaan Pengemaskinian Status Bahan Aktif Magnolia Officinalis Dalam Drug Registration Guidance Document (DRGD)
published on 2022-05-26


Perlaksanaan Pemeriksaan Regulatori Dalam dan Luar Negara Secara Lapangan ('On-Site') oleh Bahagian Regulatori Farmasi Negara (NPRA)
published on 2022-05-24


List Of GLP Compliant Test Facilities
published on 2022-05-23


Cold Chain Facilities List
published on 2022-05-20


Safety Updates on COVID-19 Vaccines: Risk of Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) / Thrombosis with Thrombocytopenia Syndrome (TTS)
published on 2022-05-17


Warfarin: Risk of Anticoagulant-Related Nephropathy (ARN)
published on 2022-05-06


Hydrochlorothiazide, Chlorthalidone, Indapamide and Acetazolamide: Risk of Choroidal Effusion, Acute Myopia & Acute Angle-Closure Glaucoma
published on 2022-05-05


Refund Procedure Involving Online Payment Made Via National Pharmaceutical Regulatory Agency QUEST3+ System
published on 2022-04-27


Kenyataan Media Pengarah NPRA 13 April 2022 - Status Laporan Kesan Advers Susulan Imunisasi (AEFI) Vaksin COVID-19 Sehingga 8 April 2022
published on 2022-04-14


Direktif untuk semua produk (termasuk kombinasi) yang mengandungi hydrochlorothiazide, indapamide, chlorthalidone dan acetazolamide: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko choroidal effusion, acute myopia dan acute angle-closure glaucoma
published on 2022-04-12


Direktif untuk semua produk yang mengandungi warfarin : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko anticoagulant-related nephropathy (ARN)
published on 2022-04-12


Direktif untuk semua produk yang mengandungi co-trimoxazole (sulfamethoxazole, trimethoprim): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko acute respiratory distress syndrome (ARDS)
published on 2022-04-12


Direktif berkenaan penambahan pernyataan amaran bagi produk suplemen kesihatan yang mengandungi bahan aktif Alpha Lipoic Acid
published on 2022-04-12


Kenyataan Media Pengarah NPRA 6 April 2022 - Status Laporan Kesan Advers Susulan Imunisasi (AEFI) Vaksin COVID-19 Sehingga 1 April 2022
published on 2022-04-07


Betamethasone (Systemic): Risk of Pheochromocytoma Crisis
published on 2022-04-06


Kenyataan Media Pengarah NPRA 30 Mac 2022 - Status Laporan Kesan Advers Susulan Imunisasi (AEFI) Vaksin COVID-19 Sehingga 25 Mac 2022
published on 2022-03-30


Frequently Asked Questions About COVID-19 Vaccines
published on 2022-03-29


Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection (1st Edition, March 2022)
published on 2022-03-29


Kenyataan Media Pengarah NPRA 24 Mac 2022 - Status Laporan Kesan Advers Susulan Imunisasi (AEFI) Vaksin COVID-19 Sehingga 18 Mac 2022
published on 2022-03-28


Tenofovir Alafenamide: Risk of Renal Adverse Effects
published on 2022-03-21


Kenyataan Media Pengarah NPRA 16 Mac 2022 - Status Laporan Kesan Advers Susulan Imunisasi (AEFI) Vaksin COVID-19 Sehingga 11 Mac 2022
published on 2022-03-18


Guidance and Requirements on Conditional Registration of Pharmaceutical Products During Disaster
published on 2022-03-15


NPRA/PKPSR-001: Borang Permohonan Kebenaran Mengimport Keluaran Tidak Berdaftar Bagi Tujuan Dieksportkan Semula
published on 2022-03-10


Kenyataan Media Pengarah NPRA 9 Mac 2022 - Status Laporan Kesan Advers Susulan Imunisasi (AEFI) Vaksin COVID-19 Sehingga 4 Mac 2022
published on 2022-03-10


Kenyataan Media Bahagian Regulatori Farmasi Negara KKM - Status Laporan Kesan Advers Susulan Imunisasi (AEFI) Vaksin COVID-19 Sehingga 25 Februari 2022
published on 2022-03-04


Kenyataan Media Pengarah NPRA 23 Februari 2022 - Status Laporan Kesan Advers Susulan Imunisasi (AEFI) Vaksin COVID-19 Sehingga 18 Februari 2022
published on 2022-02-24


Kenyataan Media Pengarah NPRA 16 Februari 2022 - Status Laporan Kesan Advers Susulan Imunisasi (AEFI) Vaksin COVID-19 Sehingga 11 Februari 2022
published on 2022-02-18


Guide on How to Upload the BE Study Report in Quest 3+ System Under Section P9
published on 2022-02-17


NPRA Customer Satisfaction Survey 2022
published on 2022-01-31


Approved Clinical Trial Import License & Clinical Trial Exemption (CTX) Application
published on 2022-01-27


Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Second Revision January 2022
published on 2022-01-26


PEKELILING BERKENAAN PENDAFTARAN PRODUK PEMBASMI KUMAN PADA PERMUKAAN BENDA (SURFACE DISINFECTANT) SECARA SUKARELA (VOLUNTARY REGISTRATION)
published on 2022-01-01


Janus Kinase (JAK) Inhibitors in Rheumatoid Arthritis Patients: Risk of Major Adverse Cardiovascular Events (MACE) and Malignancies [Excluding Non-Melanoma Skin Cancer (NMSC)]
published on 2021-12-31


Clindamycin: Risk of Acute Renal Failure
published on 2021-12-31


Sulfamethoxazole & Trimethoprim (Co-Trimoxazole): Risk of Acute Respiratory Distress Syndrome (ARDS)
published on 2021-12-30


Issues on Accessing QUEST3+ with Avast Antivirus
published on 2021-12-29


Direktif untuk semua produk yang mengandungi citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine dan vortioxetine : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko postpartum haemorrhage (PPH)
published on 2021-12-22


Direktif untuk semua produk yang mengandungi decitabine: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko differentiation syndrome
published on 2021-12-21


Direktif Untuk Menerima Permohonan Kebenaran Mengilang Produk Tidak Berdaftar Untuk Tujuan Percubaan Klinikal (CTX) Bagi Produk Vaksin COVID-19 Keluaran Pengilang Tempatan Yang Menjalankan Penyelidikan dan pembangunan (R&D) di Malaysia Yang Melibatkan Kajian First-in-Human (FIH)
published on 2021-12-21


Decitabine: Risk of Differentiation Syndrome
published on 2021-12-14


Cosmetic Guidelines ( Annex I - VII )
published on 2021-12-12


List of Licensed Wholesalers in QUEST System
published on 2021-12-04


National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

 

 

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