News and safety alerts

Kenyataan Media 22 April 2024- Makluman Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual

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Hydrochlorothiazide: Risk of Acute Respiratory Distress Syndrome (ARDS)

DISCLAIMER: This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While…

Ciprofloxacin, Moxifloxacin, Levofloxacin and Ofloxacin (Fluoroquinolones) for Systemic Use (Oral and Injection): Risk of Suicidal Behaviours

DISCLAIMER: This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While…

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KENYATAAN MEDIA PENGARAH KANAN PERKHIDMATAN FARMASI 5 APRIL 2024 - KEPUTUSAN MESYUARAT PIHAK BERKUASA KAWALAN DADAH KALI KE-395 BERKENAAN KELULUSAN PERMOHONAN LESEN IMPORT PERCUBAAN KLINIKAL PRODUK BIOLOGIK BAGI PERCUBAAN KLINIKAL FIRST-IN-HUMAN (FIH)

KENYATAAN-MEDIA-KELULUSAN-PERMOHONAN-LESEN-IMPORT-PERCUBAAN-KLINIKAL-PRODUK-BIOLOGIK-BAGI-PERCUBAAN-KLINIKAL-FIRST-IN-HUMAN-FIH-

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KENYATAAN MEDIA PENGARAH KANAN PERKHIDMATAN FARMASI 6 APRIL 2024 - KEPUTUSAN MESYUARAT PIHAK BERKUASA KAWALAN DADAH KALI KE-395 BERKENAAN PELAKSANAAN PENDAFTARAN PRODUK SEMULA JADI BERDASARKAN GUIDELINE ON NATURAL PRODUCTS WITH MODERN CLAIM

KENYATAAN-MEDIA-PELAKSANAAN-PENDAFTARAN-PRODUK-SEMULA-JADI--BERDASARKAN-GUIDELINE-ON-NATURAL-PRODUCTS-WITH--MODERN-CLAIM--

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[CLOSED] Public Consultation: Malaysian Guideline for Bioequivalence Inspection 2nd Edition

The NPRA and Bioequivalence & Ethics Committee Section (BEEC) is in the process of updating and modernising the Malaysian Guideline for Bioequivalence Inspection and would like to seek your inputs to…

[INVITATION] SEMINAR: ISPE Online GDP Seminar : Module 2 (Validation & Self-Inspection Requirement for GDP Compliance)

We are pleased to inform that ISPE Malaysia is hosting a VIRTUAL/ONLINE SEMINAR module 2: Theme: ISPE Online GDP Seminar : Module 2 (Validation & Self-Inspection Requirement for GDP Compliance)…

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Makluman Penambahbaikan Proses Pengeluaran Lesen Mengimport / Lesen Pemborong melalui Penilaian dan Pemeriksaan Pra-Pelesenan

Tarikh kuat kuasa pelaksanaan adalah untuk permohonan Lesen Mengimport / Lesen Pemborong baharu tahun 2025. The effective date of implementation is for the new application of Import License /…

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KENYATAAN MEDIA PENGARAH NPRA 1 APRIL 2024 - STATUS SUPLEMEN KESIHATAN ‘BENI KOJI CHOLESTE HELP’ KELUARAN SYARIKAT KOBAYASHI PHARMACEUTICAL CO., JEPUN DI MALAYSIA

Kenyataan-Media-KKM-NPRA---STATUS-UBAT-SUPLEMEN-KESIHATAN-BENI-KOJI-RYR-KELUARAN-KOBAYASHI-PHARMACEUTICAL-CO

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Information Sharing Paper for Cosmetic Products in the 37th ASEAN Cosmetic Committee Meeting (8-9th May 2023)

We are pleased to announce that during the 37th ASEAN Cosmetic Committee Meeting held on 8 – 9 May 2023, the Committee had agreed to adopt the following information sharing papers / Sukacita…

Kenyataan Akhbar KPK 19 Mac 2024- Makluman Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual

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Domperidone: Risk of Psychiatric Withdrawal Events When Used Off-Label for Lactation Stimulation

DISCLAIMER: This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While…

[Updated] Metformin: Risk of Vitamin B12 Deficiency

DISCLAIMER: This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While…

Keputusan Mesyuarat Pihak Berkuasa Kawalan Dadah Kali Ke-383 Berkenaan Produk Orphan Medicine Koselugo

PBKD-383---Keputpusan-Mesyuarat-PBKD-Kali-Ke-383-Berkenaan-Produk-Orphan-Medicine-KOSELUGO---6-April-2023.pdf

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Keputusan Mesyuarat Pihak Berkuasa Kawalan Dadah Kali Ke-381 Berkenaan Pendaftaran Produk Ubat Veterinar Yang Mengandungi Polymyxins

PBKD-381---Keputusan-Mesyuarat-PBKD-Kali-Ke-381-Berkenaan-Pendaftaran-Produk-Ubat-Veterinar-Yang-Mengandungi-Polymixins---7-Februari-2023.pdf

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Keputusan Mesyuarat Pihak Berkuasa Kawalan Dadah Kali Ke-380 Berkenaan Pendaftaran Vaksin COVID-19

PBKD-380---Keputusan-Mesyuarat-PBKD-kali-ke-380-COMIRNATY-10mcg-MAL22016037AZ---5-Januari-2023.pdf

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Keputusan Mesyuarat Pihak Berkuasa Kawalan Dadah Kali Ke-393

Kenyataan-Media-KPK--keputusan-mesyuarat-PBKD-393-

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Statins (Atorvastatin, Rosuvastatin, Simvastatin): Interaction with Ticagrelor Leading to Increased Risk of Rhabdomyolysis

DISCLAIMER: This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While…

Bioequivalence & Ethics Committee Section Activities in 2023: At A Glance (And More)

Illustration 1: Summary Infographic of BEEC Activities in 2023 The infographic above is a summary of activities that were coordinated and carried out by the Bioequivalence and Ethics Committee (BEEC)…

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Laporan Kajian Kepuasan Pelanggan Luar NPRA Tahun 2023

Laporan-ringkas-kajian-kepuasan-pelanggan-luar-NPRA-website

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Rejection of BE Studies Conducted at the BE Centre Synapse Labs Pvt. Ltd., India following Inspection Findings by The European Medicines Agency (EMA)

Rejection letter of BE studies conducted at the BE centre Synapse Labs Pvt. Ltd. can be downloaded via the links below: 1) Original version: Penolakan Kajian Bioekuivalens (BE) yang Dijalankan oleh…

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Penolakan Kajian Bioekuivalens (BE) yang Dijalankan oleh Pusat Kajian BE Synapse Labs Pvt. Ltd. Susulan Penemuan Pemeriksaan European Medicines Agency (EMA)

Surat penolakan kajian BE yang dijalankan oleh pusat kajian BE Synapse Labs Pvt. Ltd. boleh diakses melalui pautan di bawah:- 1) Penolakan Kajian Bioekuivalens (BE) yang Dijalankan oleh Pusat Kajian…

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Imatinib: Risk of Thrombotic Microangiopathy

DISCLAIMER: This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While…

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Rivastigmine: Risks of QT Prolongation and Torsade de Pointes

DISCLAIMER: This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While…

Kenyataan Akhbar KPK 6 Disember 2023- Makluman Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual

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