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Announcements, product safety communications and regulatory updates.
Assalamualaikum & Salam Sejahtera, YBhg. Datuk / Dato' / Datin / YBrs. Dr./ Tuan / Puan, Dengan hormatnya saya merujuk kepada perkara di atas. 2. Dimaklumkan bahawa Bahagian Regulatori Farmasi Negara…
Perhatian Kepada Pentadbir UC Agensi Tarikh Mula 16 Mac 2020 Tarikh Tamat Tidak Berkenaan Kerja-kerja / Tujuan / Sebab Pasukan Keselamatan MyGovUC akan mengaktifkan pengimbasan rekod PTR dan SPF di…
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Overview In general, sulfasalazine is indicated for the treatment of ulcerative colitis, Crohn’s disease and rheumatoid arthritis. Background The National Pharmaceutical Regulatory Agency (NPRA)…
Overview Ondansetron is a 5-HT3 receptor antagonist indicated for the treatment of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. It is also indicated for prevention and…
Overview Palbociclib, ribociclib and abemaciclib are cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors used in combination with hormone therapies to treat advanced breast cancers. In Malaysia, there…
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1. Berdasarkan penilaian dan ujian makmal oleh Kementerian Kesihatan Malaysia (KKM) dan syarikat pemegang pendaftaran produk ke atas produk-produk ranitidine yang berdaftar, didapati tiga (3) produk…
Further information related to this safety issue has become available. Readers are advised to also refer to the NPRA Safety Alert on Valproate (Sodium Valproate, Valproic Acid): Potential Risks to…
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Please be informed that, with effective 17 Dec 2019, there has been a change in Administrative Procedure for Section S Revision for Registered products (Non Anti-Infective) with the expiration of the…
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1. Berdasarkan penilaian dan ujian makmal oleh Kementerian Kesihatan Malaysia (KKM) dan syarikat pemegang pendaftaran produk serta maklumat semasa daripada badan regulatori antarabangsa, setakat ini…
This is to inform that there has been an update on the Guidance Notes for Active Pharmaceutical Ingredient (API) Information Required for Product Registration. DOWNLOAD Further to the change, new…
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The HSA-NPRA Generic Medicines Work Sharing Initiative is a work sharing model for the joint collaborative assessment of a generic medicine registration application filed with both the Health…
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Overview: Retinoids are vitamin A derivatives which are used to treat several conditions mainly affecting the skin, including severe acne and psoriasis, while some are used to treat certain forms of…
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Description: Febuxostat is a non-purine selective inhibitor of xanthine oxidase that reduces the formation of uric acid. It is indicated for the treatment of chronic hyperuricaemia in conditions…
Effective immediately, the regulatory action will be taken upon a manufacturer who fails to pay GMP inspection fees within an appropriate time which is the inactivation of manufacturer status in…
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Payment method for GMP inspection fees for pharmaceutical, radiopharmaceutical and veterinary products manufacturer by prepaid effective immediately. For further information please refer to the link…
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Arahan berkenaan kaedah pembayaran fi pemeriksaan APB yang dijalankan oleh NPRA ke atas syarikat pengilang farmaseutikal, radiofarmaseutikal dan veterinar secara pra-bayar berkuatkuasa serta-merta…
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NPRA telah mengkaji semula keperluan tindakan regulatori ke atas syarikat pengilang tradisional, suplemen kesihatan dan kosmetik yang gagal menjelaskan fi pemeriksaan APB. Ini akan melibatkan…
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Soalan 1: Apakah N-Nitrosodimethylamine (NDMA)? N-Nitrosodimethylamine (NDMA) merupakan salah satu impuriti daripada kumpulan nitrosamine yang biasa ditemui pada paras yang rendah, antaranya dalam…
Annual Report NPRA 2018 DOWNLOAD PDF
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Laporan Tahunan NPRA 2018 DOWNLOAD PDF
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