Official Malaysian Government Website
Newsroom
868 items
Announcements, product safety communications and regulatory updates.
Pekeliling Tarikh Pekeliling Berkenaan Pengeluaran Dua (2) Garis Panduan Farmakovigilans : (i) Malaysian Guidelines on Good Pharmacovigilance Practices (GVP) For Product Registration Holders, First…
Document attached
Perkara Tarikh Pemeriksaan Amalan Perkilangan Baik (APB) Dalam dan Luar Negara oleh Bahagian Regulatori Farmasi Negara (NPRA) Semasa Pandemik COVID-19 18 Ogos 2021
Document attached
Document attached
Overview Mycophenolic acid (MPA) is an immunosuppressant that is potent, selective, non-competitive and is a reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), which is involved in…
Direktif Tarikh Direktif untuk Penggunaan Drug Registration Guidance Document (DRGD) Third Edition, First Revision July 2021 22 Julai 2021
Document attached
Pekeliling Tarikh Senarai produk tidak berdaftar/berdaftar tetapi tidak dipasarkan yang diperlukan untuk rawatan pesakit 27 Julai 2021
Document attached
Overview Oseltamivir is indicated for the treatment and prophylaxis of influenza and is available in the form of capsules and oral suspension.1 Background The National Pharmaceutical Regulatory…
Direktif Tarikh Direktif untuk semua produk yang mengandungi Ceftriaxone: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko encephalopathy 14 Jun 2021
Document attached
Document attached
Document Date Awareness and Training on Quality Control in Herbal Raw Materials for Natural Product Manufacturing 25 May 2021
Document attached
Guidance Document Date GARIS PANDUAN PENGIKTIRAFAN MAKMAL SWASTA OLEH BAHAGIAN REGULATORI FARMASI NEGARA (NPRA), KEMENTERIAN KESIHATAN MALAYSIA (KKM) BAGI PERKHIDMATAN ANALISIS PRODUK TRADISIONAL 20…
Document attached
Click image to view OR Download at https://www.npra.gov.my/index.php/en/informationen/annual-reports/npra-annual-reports.html
Document attached
Document attached
Direktif Tarikh Direktif berkenaan pelaksanaan aktiviti Lot Release ke atas produk vaksin dan produk plasma yang dikilangkan di Malaysia Lampiran A - Guidance Document for Lot Release of Biological…
Document attached
Overview Postpartum haemorrhage (PPH) is referred to as the loss of 500 ml of blood or more during the first 24 hours following delivery.1 The prevalence rate of PPH is approximately 5% of all women…
Document attached
In Malaysia, Tecentriq® (atezolizumab) is approved for the treatment of non-small cell lung cancer, small cell lung cancer and triple-negative breast cancer. Based on a cumulative analysis on the…
Overview Vascular endothelial growth factor (VEGF) inhibitors are indicated for the treatment of various types of cancers, including renal cell carcinoma, hepatocellular carcinoma, thyroid and soft…
Document attached
Overview Mirtazapine is an antidepressant agent that is indicated for the treatment of major depression.1 In Malaysia, there are currently six (6) registered oral products containing mirtazapine…
Document attached
Overview Ceftriaxone is a third-generation cephalosporin antibiotic with a broad spectrum of activity against gram-negative and gram-positive micro-organisms.1 Encephalopathy is a term for any…
Document attached
Makluman Tarikh Direktif untuk semua produk yang mengandungi mengandungi Mirtazapine: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan…
Document attached
Makluman Tarikh Direktif untuk semua produk yang mengandungi Rocuronium: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko Kounis Syndrome 14 April 2021
Document attached
Makluman Tarikh Direktif untuk semua produk yang mengandungi Vascular Endothelial Growth Factor (VEGF) Inhibitors untuk kegunaan sistemik (kecuali kegunaan pada mata): Pengemaskinian sisip bungkusan…
Document attached
Makluman Tarikh Direktif berkenaan pendaftaran bersyarat secara recognition berdasarkan WHO Emergency Use Listing (EUL) bagi Vaksin COVID-19 di bawah COVAX Facility 14 April 2021
Document attached
Kenyataan-Akhbar-Apr-2021
Document attached
Document attached
