Recent Updates for Industries

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List of Renewal Approved Veterinary Products
published on 2020-10-07


Additional Indications Approved
published on 2020-10-06


New Products Approved
published on 2020-10-06


Biosimilars Approved
published on 2020-10-01


Guideline For Registration of Drug-Medical Device And Medical Device-Drug Combination Products 3rd Edition, 2020
published on 2020-09-23


Direktif berkenaan pindaan syarat pendaftaran khas bagi produk yang mengandungi oral retinoid yang diindikasikan untuk rawatan penyakit kulit
published on 2020-09-15


PEKELILING BERKENAAN PENDAFTARAN PRODUK PEMBASMI KUMAN PADA PERMUKAAN BENDA (SURFACE DISINFECTANT) SECARA SUKARELA (VOLUNTARY REGISTRATION)
published on 2020-09-10


Gilenya® (fingolimod): New contraindication in pregnant women and in women of childbearing potential who are not using effective contraception
published on 2020-09-08


Parenteral nutrition containing amino acids and/or lipids: Risk of toxic degradations of ingredients when exposed to light, which may lead to adverse outcomes in paediatric patients less than 2 years of age
published on 2020-08-27


Application Forms for Clinical Trial
published on 2020-08-26


Guidelines for Clinical Trial
published on 2020-08-26


Propofol: Risk of priapism
published on 2020-08-25


Approved Clinical Trial Import License & Clinical Trial Exemption (CTX) Application
published on 2020-08-19


Direktif untuk semua produk yang mengandungi propofol: Pengemaskinian sisip bungkusan dengan penambahan maklumat keselamatan berkaitan risiko priapism
published on 2020-08-18


Direktif untuk semua produk parenteral nutrition yang mengandungi asid amino dan/atau lipid (yang indikasinya termasuk untuk kegunaan dalam kalangan golongan pediatrik di bawah usia dua tahun): Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan kesan advers (adverse outcomes) akibat pendedahan produk kepada cahaya semasa administrasi
published on 2020-08-18


Direktif untuk semua produk yang mengandungi topiramate: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko uveitis
published on 2020-08-18


Plaquenil® (hydroxycholoroquine): Risk of QT prolongation and other drug-drug interactions in the context of COVID-19 management
published on 2020-08-14


Topiramate: Risk of uveitis
published on 2020-08-06


Insulin: Risk of cutaneous amyloidosis
published on 2020-08-06


Direktif Pemansuhan Keperluan Penghantaran Notifikasi Kajian Bioekuivalens (BE) kepada Bahagian Regulatori Farmasi Negara (NPRA)
published on 2020-07-21


Direktif Pelaksanaan Penilaian Keperluan Pemeriksaan Kajian Bioekuivalens (BE)
published on 2020-07-21


PEMERIKSAAN DALAM NEGARA DAN PENANGGUHAN PEMERIKSAAN LUAR NEGARA OLEH NPRA BERIKUTAN INSIDEN COVID-19
published on 2020-07-21


Pekeliling berkenaan perubahan prosedur kerja beberapa kategori variasi Minor Variation (Prior Approval) kepada Minor Variation (Notification) “Do & Tell” bagi produk farmaseutikal veterinar
published on 2020-07-21


Pekeliling berkenaan pelaksanaan Guidelines on Abridged Registration Pathway for Veterinary Products
published on 2020-07-21


e-ENGAGEMENT SESSION: PHASES OF IMPLEMENTATION OF ROUTINE GOOD DISTRIBUTION PRACTICE (GDP) INSPECTION ON IMPORTER AND WHOLESALER OF COLD CHAIN PRODUCT / TIME & TEMPERATURE SENSITIVE PRODUCT (TTSP)
published on 2020-07-16


SESI e-ENGAGEMENT: PELAKSANAAN PELAN BERFASA PEMERIKSAAN AMALAN PENGEDARAN BAIK (AEB) SECARA RUTIN KE ATAS PENGIMPORT DAN PEMBORONG PRODUK RANGKAIAN SEJUK / ‘TIME & TEMPERATURE SENSITIVE PRODUCT’ (TTSP)
published on 2020-07-16


List of priority products for next JA activity
published on 2020-07-16


STEPS IN JA PROCESS and timeline
published on 2020-07-16


Pekeliling Berkenaan Pengemaskinian MiV-N Do & Tell Untuk Produk Farmaseutikal, Suplemen Kesihatan Dan Produk Semulajadi
published on 2020-07-12


Direktif Penggunaan DRGD Second Edition, July 2020 Revision
published on 2020-07-10


Direktif Untuk Penggunaan Drug Registration Guidance Document (DRGD) Second Edition, September 2016, July 2020 Revision
published on 2020-07-10


ASEAN Joint Assessment Procedure for Pharmaceutical Products Information for applicants
published on 2020-07-09


ASEAN Joint Assessment Procedure for Pharmaceutical Products Public Announcement
published on 2020-07-09


Garis Panduan Persediaan Pemeriksaan Amalan Perkilangan Baik (APB) Bagi Pengilang Produk Tradisional, Suplemen Kesihatan, Dan Kosmetik
published on 2020-06-29


Guidance Document For Preparation Of Good Manufacturing Practice (GMP) Inspections On Traditional Medicines, Health Supplements And Cosmetics Manufacturers
published on 2020-06-29


Reminder on the risk of oculogyric crisis with metoclopramide use
published on 2020-06-23


Direktif pendaftaran produk semulajadi dengan tuntutan terapeutik berdasarkan Guideline on Natural Products with Therapeutic Claim
published on 2020-06-22


Pusat Kutipan Permit / Sijil / Lesen Setempat Di NPRA
published on 2020-06-21


Pekeliling berkenaan pelaksanaan prosedur kerja Fast-Track bagi permohonan lesen import percubaan klinikal dan kebenaran mengilang produk tidak berdaftar untuk tujuan percubaan klinikal
published on 2020-06-19


Domperidone: Restriction of use in paediatric patients less than 12 years of age
published on 2020-06-04


SOALAN-SOALAN LAZIM BERKENAAN PEMERIKSAAN AMALAN PERKILANGAN BAIK (APB) DAN AMALAN PENGEDARAN BAIK (AEB) OLEH BAHAGIAN REGULATORI FARMASI NEGARA (NPRA) SEMASA PANDEMIK COVID-19
published on 2020-06-03


Proton pump inhibitors: Risk of microscopic colitis
published on 2020-05-28


Gabapentin: Risk of dysphagia
published on 2020-05-27


Pekeliling Berkenaan Prosedur Kerja Desktop Assessment Ke Atas Pengilang Tradisional Dan Suplemen Kesihatan (TMHS) Luar Negara Bagi Tujuan Pengesahan Pematuhan Amalan Perkilangan Baik (APB)
published on 2020-05-19


Direktif keperluan menjalankan ujian fizikal untuk aktiviti Lot Release bagi semua vaksin dan produk plasma berdaftar
published on 2020-05-15


Direktif penerimaan keputusan pengujian pra-pendaftaran produk semulajadi dari makmal swasta yang telah diiktiraf oleh NPRA dan makmal kawalan kualiti pengilang tempatan
published on 2020-05-15


Direktif untuk semua produk yang mengandungi Proton Pump Inhibitors (PPI) termasuk produk kombinasi: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan maklumat keselamatan berkaitan Microscopic Colitis
published on 2020-05-15


Direktif untuk semua produk yang mengandungi domperidone: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan maklumat berkaitan penggunaan dalam kalangan golongan pediatrik
published on 2020-05-15


Direktif untuk semua produk yang mengandungi gabapentin: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan penambahan maklumat keselamatan berkaitan risiko dysphagia
published on 2020-05-15


Direktif untuk semua produk yang mengandungi Diclofenac (kecuali sediaan untuk kegunaan pada kulit): Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan penambahan maklumat keselamatan berkaitan risiko anastomotic leakage dan kounis syndrome
published on 2020-05-15


Guidance Document on Verification of Translated Official Document - May 2020
published on 2020-05-13


Rocuronium: Kounis syndrome
published on 2020-05-12


Nintedanib: Ischaemic colitis
published on 2020-05-12


Guselkumab: Risk of anaphylaxis
published on 2020-04-07


Esmya (ulipristal acetate 5 mg): Product recall due to potential risk of liver injury
published on 2020-04-06


Intravenous iron-containing products: Kounis syndrome
published on 2020-04-06


Nivolumab: Reports of cytomegalovirus (CMV) infection or reactivation
published on 2020-04-06


Kyprolis® (carfilzomib): (i) Risk of progressive multifocal leukoencephalopathy (PML); (ii) Risk of hepatitis B virus (HBV) reactivation 
published on 2020-04-06


Esbriet® (pirfenidone): Drug-induced liver injury (DILI)
published on 2020-04-06


Q & A Hand Sanitizer
published on 2020-04-03


MADRAC Bulletin - 03/2019 Edition
published on 2020-03-30


Penangguhan Semua Pemeriksaan Dalam dan Luar Negara oleh NPRA Berikutan Penularan Wabak COVID-19
published on 2020-03-23


PERLAKSANAAN PERINTAH KAWALAN PERGERAKAN DI PREMIS NPRA / IMPLEMENTATION OF MOVEMENT CONTROL ORDER IN NPRA
published on 2020-03-17


Direktif pertimbangan pengecualian keperluan data bioekuivalens (BE) bagi produk generik dalam bentuk oral solid, immediate release yang mengemukakan permohonan pendaftaran semula
published on 2020-03-11


Makluman Berkaitan Pelaksanaan Guidance Document for Pre-Submission Meeting
published on 2020-03-06


Sulfasalazine: Interference with dihydronicotinamide-adenine dinucleotide/ dihydronicotinamide-adenine dinucleotide phosphate (NADH/NADPH) reaction assays
published on 2020-02-26


Ondansetron: Birth defects
published on 2020-02-26


Cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors: Risk of severe lung inflammation
published on 2020-02-26


Philippines FDA included in list of ASEAN Listed Inspection Services
published on 2020-01-21


New safety measure for sodium valproate: (i) Risk of congenital malformation in neonates and neurodevelopmental problems in children exposed to sodium valproate during pregnancy; (ii) Additional educational material for healthcare professionals and patients/caretakers
published on 2020-01-20


Direktif untuk semua produk yang mengandungi sulfasalazine: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko gangguan terhadap ujian makmal yang menggunakan reaksi dihydronicotinamide-adenine dinucleotide/ dihydronicotinamide-adenine dinucleotide phosphate (NADH/NADPH)
published on 2020-01-09


Direktif untuk semua produk yang mengandungi sodium valproate: pengukuhan maklumat keselamatan pada label, sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) berkaitan risiko kecacatan kongenital dan masalah perkembangan dalam kalangan bayi dan kanak-kanak yang terdedah kepada penggunaan sodium valproate semasa dalam kandungan dan penyediaan bahan-bahan pengajaran
published on 2020-01-09


Malaysia Comparator Product (MCP) for BE Study
published on 2019-12-31


New Chemical Entities
published on 2019-12-19


Second Source and Replacement Products
published on 2019-12-04


Direktif untuk semua produk yang mengandungi carbimazole atau methimazole (thiamazole): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko pankreatitis akut (acute pancreatitis) dan pengukuhan maklumat keselamatan berkaitan risiko kecacatan kongenital (congenital malformation)
published on 2019-12-04


Direktif untuk semua produk yang mengandungi loperamide: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan unmasking Brugada syndrome dengan pengambilan dos berlebihan
published on 2019-12-04


HSA-NPRA Generic Medicines Work Sharing Initiative
published on 2019-11-26


Retinoids: Updated measures for pregnancy prevention during retinoids use
published on 2019-11-26


FEBURIC® (febuxostat): Increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study
published on 2019-11-26


Traditional, Health Supplement & Cosmetics Manufacturer: Regulatory Act upon Manufacturer with Unpaid GMP Inspection Fees
published on 2019-11-13


Pharmaceutical, Radiopharmaceutical & Veterinary Products Manufacturer: Prepaid GMP Inspection Fees
published on 2019-11-13


Berita Ubat-Ubatan September 2019
published on 2019-11-13


Drug Registration Guidance Document : Second Edition – September 2016, July 2020 Revision
published on 2019-11-01


Smecta® (dioctahedral smectite): Not recommended for use in children aged below 2 years and pregnant or breastfeeding women
published on 2019-10-30


Berita Ubat-Ubatan April 2019
published on 2019-10-30


Keperluan Acknowledgement Receipt/ Endorsement Letter bagi pendaftaran baru/ pendaftaran semula produk kombinasi ubat-peranti perubatan (Drug-Medical Device Combination)
published on 2019-10-14


Penguatkuasaan keperluan kajian bioekuivalens (BE) dan akreditasi pusat kajian BE bagi produk generik tetapi produk inovator tidak pernah didaftarkan di Malaysia
published on 2019-10-03


Penggunaan label keselamatan baharu dari pembekal yang dilantik oleh Kementerian Kesihatan Malaysia
published on 2019-09-27


Direktif untuk semua produk yang mengandungi retinoid yang diindikasikan untuk rawatan penyakit kulit (termasuk topikal): pengemaskinian label, sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) bagi memperkukuhkan maklumat keselamatan berkaitan kesan teratogenik dan penyediaan bahan-bahan pengajaran
published on 2019-09-27


Clopidogrel: Interaction with boosted antiviral Human Immunodeficiency Virus (HIV) therapy leading to insufficient inhibition of platelet aggregation
published on 2019-09-03


LEMTRADA® (alemtuzumab): (i) Risk of autoimmune hepatitis (ii) Other serious reactions temporally associated with alemtuzumab infusion (iii) Haemophagocytic lymphohistiocytosis
published on 2019-09-03


Diclofenac (systemic use): (i) Risk of anastomotic leakage and (ii) Risk of Kounis syndrome
published on 2019-08-26


Actemra® (tocilizumab): New important identified risk of hepatotoxicity
published on 2019-08-26


List of Licensed Wholesalers in QUEST System
published on 2019-08-14


List of Licensed Manufacturers in QUEST System
published on 2019-08-14


List of Cosmetic Manufacturers in QUEST System
published on 2019-08-13


Kenyataan Akhbar KPK 6 Ogos 2019 – Produk-Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual
published on 2019-08-06


Manufacturer's / Importer's / Wholesaler's Licence Renewal Application for Year 2020
published on 2019-08-05


Direktif untuk semua produk yang mengandungi hydrochlorothiazide termasuk kombinasi: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan penambahan maklumat keselamatan berkaitan non-melanoma skin cancer
published on 2019-07-19


National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 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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