News and safety alerts

Pseudoephedrine: Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS)

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…

Fluconazole: Updates on the Known Risk of Spontaneous Abortion During Pregnancy and Congenital Malformations in Children Exposed to Fluconazole in Utero

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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Paracetamol and Fixed Drug Eruption (FDE): Upward Trend of Reports Involving Paediatric Patients

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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Latihan Kawalan Kualiti ke atas Bahan Mentah Herba dan Produk Semula Jadi

Latihan Kawalan Kualiti ke atas Bahan Mentah Herba dan Produk Semula Jadi Sila ambil maklum bahawa peserta yang berjaya menempatkan diri dalam latihan ini telah menerima satu e-mel pengesahan pada…

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Safety Signal Alert: Mefenamic Acid-Associated Generalised Bullous Fixed Drug Eruption (GBFDE)

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…

NOTIS MAKLUMAN URUSAN PEMBAYARAN BANK DRAF ATAU KIRIMAN WANG BAGI PERMOHONAN PEMERIKSAAN PUSAT KAJIAN BE

Salam sejahtera, NOTIS PENTING: Adalah dimaklumkan bahawa bermula 15 Ogos 2024, segala urusan pembayaran kepada NPRA hendaklah dibuat ke atas nama “BAHAGIAN REGULATORI FARMASI NEGARA” dan bukan lagi…

Progestogens (Cyproterone Acetate, Medroxyprogesterone Acetate, Chlormadinone): Risk of Meningioma

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…

Azacitidine (Injectable Formulation): Risk of Cutaneous Vasculitis

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…

Announcement to Product Registration Holders (PRHs): Revision of Categories and Criteria for New/Additional Indication Application – A Pilot Study

As we progress towards implementing reliance throughout the product life cycle, we plan to expand the implementation of reliance to include new/additional indication applications beginning with a…

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Kenyataan Media KKM 5 Ogos 2024- Makluman Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual

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Deficiency Analysis in On-Site Good Manufacturing Practice (GMP) Inspections of Manufacturers for Medicinal Products and Cosmetics by National Pharmaceutical Regulatory Agency (NPRA)

National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health as a secretariat of Drug Control Authority (DCA) is responsible to ensure the quality, safety and efficacy of registered products…

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17-Hydroxyprogesterone Caproate (17-OHPC): Potential Cancer Risk in Offspring Exposed in Utero and Limited Efficacy Data

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…

Pre-Membership Module Announcement

We have created a pre-membership module page for users to access our online forms. This page is for unregistered users needing access to pre-membership online forms linked to the QUEST3+ system. The…

Hydroxychloroquine: Risk of Sweet’s Syndrome (Acute Febrile Neutrophilic Dermatosis)

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 Media KPK 9 Julai 2024- Makluman Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual

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Anti-Clusters of Differentiation 20 (CD20) Antibodies (Rituximab, Obinutuzumab, Ofatumumab, Ocrelizumab): Risk of Pyoderma Gangrenosum

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…

Registration Application Submitted via Facilitated Registration Pathway (FRP) - FAQs

For more information regarding registration application submitted via Facilitated Registration Pathway (FRP), kindly refer to the Frequently Asked Questions (FAQs)

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Kenyataan Media KPK 29 Mei 2024- Makluman Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual

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Amoxicillin: Risk of Aseptic Meningitis

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…

Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors (Dapagliflozin, Empagliflozin, Canagliflozin): Interaction with Lithium (for Therapeutic Use) Leading to Decreased Serum Lithium Concentration

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 MEDIA KEMENTERIAN KESIHATAN MALAYSIA - MAJLIS MENANDATANGANI SEMULA MEMORANDUM PERSEFAHAMAN ANTARA KERAJAAN MALAYSIA DAN THE HEALTH SCIENCES AUTHORITY (HSA) OF SINGAPORE BAGI KERJASAMA DALAM BIDANG REGULATORI FARMASEUTIKAL PADA 6 MEI 2024

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Revision of timelines for variation applications of registered products [pharmaceutical products & natural and health supplement products (TMHS)] and a pilot study

For information, NPRA is continuously working towards improved efficiency, not only for pre-marketing product assessments but also for post-approval changes. To provide greater clarity and more…

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[Updated] Olmesartan: Risk of Autoimmune Hepatitis

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…

Proton Pump Inhibitors: Risk of Erectile Dysfunction

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…

Levetiracetam and Clobazam: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

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…