Bioequivalence & Ethics Committee Section Activities: 2024 Key Activities and Performance
published on 2025-06-11
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Screening Package for New Drug Products and Biologics
published on 2025-06-03
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Additional Indications Approved
published on 2025-05-29
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Angiotensin II Receptor Blockers (ARBs): Risk of Intestinal Angioedema
published on 2025-05-28
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New Products Approved
published on 2025-05-27
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Pekeliling Berkenaan Penggunaan Kod QR oleh Pemegang Pendaftaran Produk (PRH) Bagi Tujuan Pengedaran Additional Risk Minimisation Materials (aRMM) Kepada Anggota Kesihatan dan Pesakit
published on 2025-05-27
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[Updated] Statins: Risk of Inducing or Aggravating Myasthenia Gravis
published on 2025-05-26
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Isotretinoin: Risk of Sacroiliitis and Urethritis
published on 2025-05-26
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FREQUENTLY ASKED QUESTION (FAQ) On the use of CHLOROFORM in product formulation following the directive issued on 19th November 2024: DIREKTIF BERKENAAN LARANGAN PENGGUNAAN CHLOROFORM/CHLOROFORM SPIRIT SEBAGAI PENGAWET DALAM PRODUK FARMASEUTIKAL, PRODUK SEMULA JADI DAN PRODUK SUPLEMEN
published on 2025-05-26
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Guidance Document: Verification for Traditional Medicines (TM) & Health Supplements (HS) Manufacturers, Second Edition, May 2025
published on 2025-05-21
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Guidance Document: Verification for Traditional Medicines (TM) & Health Supplements (HS) Manufacturers, Second Edition, May 2025
published on 2025-05-21
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Enoxaparin: Risk of Acute Generalised Exanthematous Pustulosis (AGEP)
published on 2025-05-21
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Azathioprine: Risk of Non-Cirrhotic Portal Hypertension (NCPH) / Portosinusoidal Vascular Disease (PVSD)
published on 2025-05-20
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List of Renewal Approved Veterinary Products
published on 2025-05-13
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Direktif untuk semua produk yang mengandungi rituximab (sediaan injeksi sahaja) : Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko enteroviral meningoencephalitis dan false negative serologic testing of infections
published on 2025-05-13
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Direktif untuk semua produk yang mengandungi isotretinoin : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko sacroiliitis dan urethritis
published on 2025-05-13
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Direktif untuk semua produk yang mengandungi statin (termasuk produk kombinasi): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko myasthenia gravis
published on 2025-05-13
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Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2024
published on 2025-05-05
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Azithromycin: Rare Risk of Cardiovascular Death
published on 2025-04-24
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Outcome of GVP Inspection Voluntary Phase (2023-2024): Preliminary Key Findings & Trends
published on 2025-04-16
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Direktif berkenaan penambahbaikan proses permohonan pendaftaran produk untuk tujuan eksport sahaja/ For Export Only (FEO) bagi produk farmaseutikal, suplemen kesihatan dan produk semulajadi
published on 2025-04-10
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Direktif Berkenaan Peluasan Skop Produk Kajian Klinikal First-In-Human (FIH) Untuk Permohonan Lesen Import Percubaan Klinikal (CTIL) dan Kebenaran Untuk Mengilang Produk Tidak Berdaftar Untuk Tujuan Percubaan Klinikal (CTX) kepada Cell and Gene Therapy Product (CGTP)
published on 2025-03-14
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Pengemaskinian Garis Panduan Pelaksanaan Risalah Maklumat Ubat Untuk Pengguna (RiMUP)
published on 2025-03-07
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Biosimilar Approved
published on 2025-03-05
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Hydroxychloroquine: Small Increased Risk of Major Congenital Malformations in Children Following in utero Exposure
published on 2025-03-04
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Perluasan Skop Keperluan Akreditasi Pusat Kajian Bioekuivalens (BE) dan Pengecualian Penilaian Keperluan Pemeriksaan Kajian BE Bagi Tujuan Pendaftaran Produk
published on 2025-02-19
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Direktif Berkenaan Pengemaskinian Prosedur Permohonan Pertukaran Pemegang Pendaftaran Produk (COH)
published on 2025-02-19
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NPRA Regulatory Updates 2025
published on 2025-02-13
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DCA News
published on 2025-01-23
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Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Ninth Revision January 2025
published on 2025-01-21
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Glucagon-like Peptide-1 (GLP-1) Receptor Agonists (Dulaglutide, Liraglutide, Lixisenatide, Semaglutide, and Tirzepatide): Aspiration and Pneumonia Aspiration during General Anaesthesia or Deep Sedation
published on 2025-01-21
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Guidelines for Clinical Trial
published on 2025-01-09
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Ethambutol: Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
published on 2025-01-09
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PEKELILING MAKLUMAN BERKENAAN PELAKSANAAN PENILAIAN PROTOKOL ANALISA SEBAGAI PERSEDIAAN PEMINDAHAN TATACARA PENGUJIAN BAGI PRODUK VAKSIN YANG BERDAFTAR DI MALAYSIA
published on 2025-01-07
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PEKELILING BIL 3/2024 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA
published on 2024-12-30
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Application Forms for Clinical Trial
published on 2024-12-20
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Frequently Asked Questions (FAQs): Appendix 19 General Labelling Requirement for Products Containing Animal-Derived Materials
published on 2024-12-13
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New Drug Products (NCE)
published on 2024-12-05
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[Updated November 2024] Product Classification Form - N1-FR-02/2
published on 2024-11-28
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Approved Clinical Trial Import License & Clinical Trial Exemption (CTX) Application
published on 2024-11-21
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Direktif berkenaan larangan penggunaan chloroform/chloroform spirit sebagai pengawet dalam produk farmaseutikal, produk semula jadi dan produk suplemen kesihatan
published on 2024-11-19
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Announcement to Product Registration Holders (PRHs): Pilot Project for Post-Approval Changes (Variation) Using Reliance
published on 2024-11-15
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🙏Thanks for Joining #MedSafetyWeek! 💊🌍
published on 2024-11-10
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💊 Medicines Are Continually Monitored to Ensure Their Safety 🔍
published on 2024-11-09
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❓ 5️⃣Questions to Ask Your Patients to Help Prevent Side Effects 💊
published on 2024-11-07
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❓ 5️⃣Questions to Ask Your Healthcare Professional to Help Prevent Side Effects 💊
published on 2024-11-07
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💊 Not All Medicines Are Equal ⚖️
published on 2024-11-06
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Not All Medicines Are Suitable for Everyone 👶👧🏾👦👨🏻👴👵🤰🏻
published on 2024-11-05
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Kenyataan Media Kementerian Kesihatan Malaysia - Pelancaran Minggu Keselamatan Ubat #MedSafetyWeek 2024
published on 2024-11-05
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💊 Prevent Side Effects by Taking Medicines the Right Way! ✅
published on 2024-11-04
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Sesi Libat Urus antara Bahagian Regulatori Farmasi Negara (NPRA) bersama Pihak Berkepentingan (STAKEHOLDERS)
published on 2024-11-04
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📣 #MedSafetyWeek Starts Today!
published on 2024-11-04
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We’re Ready for #MedSafetyWeek – Are You? ⏱️
published on 2024-10-31
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📆 Join Us Next Week for #MedSafetyWeek!
published on 2024-10-28
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[Updated] 17-Hydroxyprogesterone Caproate (17-OHPC): Cancellation of Product Registration and Product Recall
published on 2024-10-14
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Paracetamol and Fixed Drug Eruption (FDE): Upward Trend of Reports Involving Paediatric Patients
published on 2024-10-10
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KENYATAAN MEDIA KEMENTERIAN KESIHATAN MALAYSIA 8 OKTOBER 2024 - KELULUSAN PENDAFTARAN BAGI PRODUK SEMULA JADI DENGAN TUNTUTAN MODEN
published on 2024-10-08
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Data Exclusivity
published on 2024-10-04
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Kenyataan Media KKM 02 Oktober 2024- Makluman Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual
published on 2024-10-02
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Kenyataan Media KKM 30 September 2024- Makluman Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual
published on 2024-10-01
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Fluconazole: Updates on the Known Risk of Spontaneous Abortion During Pregnancy and Congenital Malformations in Children Exposed to Fluconazole in Utero
published on 2024-10-01
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Pseudoephedrine: Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS)
published on 2024-09-30
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Prosedur dan Kriteria Pelanjutan Tempoh Sah Pusat Kajian Bioekuivalens (BE) dan Jawatankuasa Etika yang berdaftar dengan Pihak Berkuasa Kawalan Dadah (PBKD)
published on 2024-09-19
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Penerbitan Garis Panduan Malaysian Guideline For Bioequivalence Inspection Edisi Kedua
published on 2024-09-19
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Safety Signal Alert: Mefenamic Acid-Associated Generalised Bullous Fixed Drug Eruption (GBFDE)
published on 2024-09-02
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Garis Panduan Penilaian Kesetaraan Taraf Amalan Perkilangan Baik (APB) Pengilang TMHS Luar Negara, Edisi Pertama, September 2024
published on 2024-08-30
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Progestogens (Cyproterone Acetate, Medroxyprogesterone Acetate, Chlormadinone): Risk of Meningioma
published on 2024-08-25
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Pengemaskinian Drug Registration Guidance Document (DRGD) Berkaitan Keperluan Deklarasi Bahan Bersumberkan Haiwan Pada Label Produk
published on 2024-08-14
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Azacitidine (Injectable Formulation): Risk of Cutaneous Vasculitis
published on 2024-08-12
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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)
published on 2024-07-24
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Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Eighth Revision July 2024
published on 2024-07-23
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17-Hydroxyprogesterone Caproate (17-OHPC): Potential Cancer Risk in Offspring Exposed in Utero and Limited Efficacy Data
published on 2024-07-19
|
Pre-Membership Module Announcement
published on 2024-07-18
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Hydroxychloroquine: Risk of Sweet’s Syndrome (Acute Febrile Neutrophilic Dermatosis)
published on 2024-07-15
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Direktif untuk semua produk yang mengandungi Hydroxychloroquine : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko Acute Febrile Neutrophilic Dermatosis (Sweet’s Syndrome)
published on 2024-07-11
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Direktif untuk semua produk yang mengandungi Azacitidine (sediaan injeksi sahaja) : Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko Cutaneous Vasculitis
published on 2024-07-11
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Pertandingan Perarakan (Parade) sempena Majlis Perasmian Sambutan Ulang Tahun Bandaraya Petaling Jaya ke-18 dan Pra-Pelancaran Petaling Jaya International Folklore Festival 2025
published on 2024-07-10
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Anti-Clusters of Differentiation 20 (CD20) Antibodies (Rituximab, Obinutuzumab, Ofatumumab, Ocrelizumab): Risk of Pyoderma Gangrenosum
published on 2024-06-28
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PEKELILING BIL 2/2024 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA
published on 2024-06-19
|
Orphan Medicines Approved
published on 2024-06-11
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Garis Panduan Persediaan Pemeriksaan APB Bagi Pengilang Pengilang Tradisional, Suplemen Kesihatan dan Kosmetik, Edisi Keempat, Jun 2024
published on 2024-05-31
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Guidance Document For Preparation of Good Manufacturing Practice (GMP) Inspections On Traditional Medicines, Health Supplements and Cosmetics Manufacturers, Fourth Edition, June 2024
published on 2024-05-30
|
Amoxicillin: Risk of Aseptic Meningitis
published on 2024-05-29
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Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors (Dapagliflozin, Empagliflozin, Canagliflozin): Interaction with Lithium (for Therapeutic Use) Leading to Decreased Serum Lithium Concentration
published on 2024-05-28
|
Guideline on Electronic Labelling (E-Labelling) For Pharmaceutical Products in Malaysia
published on 2024-05-21
|
[Updated] Olmesartan: Risk of Autoimmune Hepatitis
published on 2024-05-06
|
Proton Pump Inhibitors: Risk of Erectile Dysfunction
published on 2024-04-30
|
Levetiracetam and Clobazam: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
published on 2024-04-29
|
Hydrochlorothiazide: Risk of Acute Respiratory Distress Syndrome (ARDS)
published on 2024-04-18
|
Ciprofloxacin, Moxifloxacin, Levofloxacin and Ofloxacin (Fluoroquinolones) for Systemic Use (Oral and Injection): Risk of Suicidal Behaviours
published on 2024-04-17
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Direktif untuk semua produk yang mengandungi hydrochlorothiazide (termasuk produk kombinasi): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) dengan maklumat keselamatan berkaitan risiko Acute Respiratory Distress Syndrome (ARDS)
published on 2024-04-16
|
Direktif untuk semua produk yang mengandungi olmesartan (termasuk produk kombinasi): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) dengan maklumat keselamatan berkaitan risiko hepatitis autoimun (autoimmune hepatitis)
published on 2024-04-16
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Direktif untuk semua produk yang mengandungi Mefenamic Acid: Pengemaskinian Sisip Bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan Generalised Bullous Fixed Drug Eruption (GBFDE)
published on 2024-04-16
|
Direktif untuk semua produk yang mengandungi ciprofloxacin, moxifloxacin, levofloxacin dan ofloxacin untuk kegunaan sistemik (sediaan oral dan injeksi) : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) dengan maklumat keselamatan berkaitan risiko suicidal behaviour
published on 2024-04-16
|
Direktif untuk semua produk yang mengandungi dapagliflozin, empagliflozin, canagliflozin (termasuk produk kombinasi) dan lithium (untuk tujuan rawatan) : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) dengan maklumat keselamatan berkaitan risiko penurunan paras serum lithium akibat interaksi ubat
published on 2024-04-16
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Direktif berkenaan pendaftaran produk semula jadi berdasarkan Guideline on Natural Products with Modern Claim
published on 2024-04-15
|
Makluman Penambahbaikan Proses Pengeluaran Lesen Mengimport / Lesen Pemborong melalui Penilaian dan Pemeriksaan Pra-Pelesenan
published on 2024-04-05
|
Information Sharing Paper for Cosmetic Products in the 37th ASEAN Cosmetic Committee Meeting (8-9th May 2023)
published on 2024-03-27
|
Direktif Berkenaan Pengemaskinian Garis Panduan Malaysian Guideline For Application Of Clinical Trial Import Licence (CTIL) And Clinical Trial Exemption (CTX)
published on 2024-03-19
|
Iklan Sebut Harga Kerja-Kerja Menaiktaraf Sistem Pendingin Hawa Di Program Perkhidmatan Farmasi, Ibu Pejabat Kementerian Kesihatan Malaysia
published on 2024-03-15
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