Recent Updates for Industries

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List of Renewal Approved Veterinary Products
published on 2022-06-23


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


Cosmetic GMP Training 2022
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


New Products Approved
published on 2022-06-10


Additional Indications Approved
published on 2022-06-07


Biosimilars Approved
published on 2022-06-02


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


MOPI Training -Virtual Good Manufacturing Training Program 2022
published on 2022-01-05


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 2021-12-03


List of Licensed Manufacturers in QUEST System
published on 2021-12-03


List of Licensed Importers in QUEST System
published on 2021-12-02


Penolakan Kajian Bioekuivalens (BE) yang Dijalankan oleh Pusat Kajian BE Synchron Research Services dan Panexcell Clinical Lab Susulan Penemuan Pemeriksaan United States Food and Drug Administration (US FDA)
published on 2021-11-29


Rejection of Bioequivalence (BE) Studies Conducted at The BE Centres Synchron Research Services and Panexcell Clinical Lab Following Inspection Findings by The United States Food and Drug Administration (US FDA)
published on 2021-11-29


Anastrozole: Risk of Depression
published on 2021-11-24


Pembatalan Arahan Bilangan 26 Tahun 2017 : Direktif Pindaan Had Harian Pengambilan Menthol Dalam Persediaan Oral
published on 2021-11-22


Kenyataan Akhbar KPK 16 Nov 2021 - Pemanjangan Jangka Hayat Produk Vaksin Jenis Coronavac dan Comirnaty
published on 2021-11-17


#MedSafetyWeek: Working together we can make vaccines better for everyone!
published on 2021-11-05


Direktif Berkenaan Keperluan Mendaftar Penyelidikan Klinikal Sukarelawan Sihat Dengan National Healthy Research Volunteer Register (NHRVR) Kepada Sponsor/Pemohon/Penyelidik Yang Memohon Lesen Import Percubaan Klinikal (CTIL) Dan Kelulusan Mengilang (CTX)
published on 2021-11-03


#MedSafetyWeek: Always #ReportSideEffects
published on 2021-11-02


#MedSafetyWeek starts today!
published on 2021-11-01


Direktif untuk semua produk yang mengandungi anastrozole: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko depression
published on 2021-10-15


Direktif untuk semua produk yang mengandungi bortezomib: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko Guillain-Barré syndrome dan demyelinating polyneuropathy
published on 2021-10-15


Direktif untuk semua produk yang mengandungi mycophenolate (mycophenolate mofetil dan mycophenolic acid): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko de novo purine synthesis inhibitors-associated acute inflammatory syndrome
published on 2021-10-15


Direktif untuk semua produk yang mengandungi insulin (termasuk produk kombinasi): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko cutaneous amyloidosis
published on 2021-10-15


Bortezomib: Risk of Guillain-Barré Syndrome and Demyelinating Polyneuropathy
published on 2021-10-12


Non-Vitamin K Antagonist Oral Anticoagulants (NOACs): Risk of Abnormal Uterine Bleeding
published on 2021-10-07


Malaysian Guidelines on Good Pharmacovigilance Pratices (GVP) for Product Registration Holders (1st Edition, August 2021)
published on 2021-09-29


Sacubitril/Valsartan: Risk of Psychiatric Events
published on 2021-09-09


HSA-NPRA Generic Medicines Work Sharing Initiative
published on 2021-09-06


Guideline for Application of Private Laboratories Complying to NPRA Requirements for Traditional Products Testing
published on 2021-09-01


Guidance Document Foreign GMP Inspection, 8th Edition, September 2021
published on 2021-08-23


Pemeriksaan Amalan Perkilangan Baik (APB) Dalam dan Luar Negara oleh Bahagian Regulatori Farmasi Negara (NPRA) Semasa Pandemik COVID-19
published on 2021-08-19


Direktif untuk Penggunaan Drug Registration Guidance Document (DRGD) Third Edition, First Revision July 2021
published on 2021-07-23


Senarai produk tidak berdaftar/berdaftar tetapi tidak dipasarkan yang diperlukan untuk rawatan pesakit
published on 2021-07-22


Oseltamivir: Risk of haemorrhages
published on 2021-07-08


Direktif untuk semua produk yang mengandungi Ceftriaxone: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko encephalopathy
published on 2021-06-14


Garis Panduan Pengiktirafan Makmal Swasta Oleh Bahagian Regulatori Farmasi Negara (Npra) Bagi Perkhidmatan Analisis Produk Tradisional
published on 2021-05-20


Pekeliling Bil 1 2021 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA
published on 2021-05-06


Direktif berkenaan pelaksanaan aktiviti Lot Release ke atas produk vaksin dan produk plasma yang dikilangkan di Malaysia
published on 2021-04-28


GARIS PANDUAN PERMOHONAN LESEN PENGILANG, LESEN MENGIMPORT DAN LESEN PEMBORONG PRODUK BERDAFTAR
published on 2021-04-28


Antidepressants (citalopram; desvenlafaxine; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline; venlafaxine; vortioxetine):  Risk of Postpartum Haemorrhage (PPH)
published on 2021-04-22


Tecentriq® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs)
published on 2021-04-22


Vascular endothelial growth factor (VEGF) inhibitors for systemic use (except application on eyes): Risk of artery dissections and aneurysms
published on 2021-04-20


Mirtazapine: Risks of (i) Amnesia and (ii) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
published on 2021-04-20


Ceftriaxone: Risk of encephalopathy
published on 2021-04-20


Direktif untuk semua produk yang mengandungi mengandungi Mirtazapine: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko amnesia dan Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
published on 2021-04-13


Direktif untuk semua produk yang mengandungi Rocuronium: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko Kounis Syndrome
published on 2021-04-13


Direktif untuk semua produk yang mengandungi Vascular Endothelial Growth Factor (VEGF) Inhibitors untuk kegunaan sistemik (kecuali kegunaan pada mata): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko artery dissections dan aneurysms
published on 2021-04-13


Direktif berkenaan pendaftaran bersyarat secara recognition berdasarkan WHO Emergency Use Listing (EUL) bagi Vaksin COVID-19 di bawah COVAX Facility
published on 2021-04-13


Keputusan Pihak Berkuasa Kawalan Dadah (PBKD) Berkenaan Penetapan Syarat Pendaftaran Bagi Vaksin COVID-19 Yang Diluluskan Pendaftaran Bersyarat Hanya Boleh Dijual Dan Dibekal Kepada Pihak Kerajaan atau Pihak Yang Dibenarkan oleh Kerajaan
published on 2021-03-11


Update on Guidance Notes for Active Pharmaceutical Ingredients (API) Information for Product Registration - Version 6.0 (March 2021)
published on 2021-03-01


Keputusan Pihak Berkuasa Kawalan Dadah (PBKD) Berkenaan Pengecualian Daripada Keperluan Menjalankan Ujian Fizikal Untuk Aktiviti Lot Release Bagi Semua Produk Vaksin COVID-19 Berdaftar Yang Diimport dan Digunakan Semasa Situasi Pandemik
published on 2021-02-19


Safety Updates on COVID-19 Vaccine (Comirnaty®)
published on 2021-02-17


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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