List of Renewal Approved Veterinary Products
published on 2024-10-16
|
[Updated] 17-Hydroxyprogesterone Caproate (17-OHPC): Cancellation of Product Registration and Product Recall
published on 2024-10-14
|
Biosimilar Approved
published on 2024-10-14
|
Paracetamol and Fixed Drug Eruption (FDE): Upward Trend of Reports Involving Paediatric Patients
published on 2024-10-10
|
New Products Approved
published on 2024-10-09
|
KENYATAAN MEDIA KEMENTERIAN KESIHATAN MALAYSIA 8 OKTOBER 2024 - KELULUSAN PENDAFTARAN BAGI PRODUK SEMULA JADI DENGAN TUNTUTAN MODEN
published on 2024-10-08
|
Additional Indications Approved
published on 2024-10-08
|
Data Exclusivity
published on 2024-10-04
|
Kenyataan Media KKM 02 Oktober 2024- Makluman Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual
published on 2024-10-02
|
Kenyataan Media KKM 30 September 2024- Makluman Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual
published on 2024-10-01
|
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
|
Pseudoephedrine: Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS)
published on 2024-09-30
|
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
|
Penerbitan Garis Panduan Malaysian Guideline For Bioequivalence Inspection Edisi Kedua
published on 2024-09-19
|
Safety Signal Alert: Mefenamic Acid-Associated Generalised Bullous Fixed Drug Eruption (GBFDE)
published on 2024-09-02
|
Garis Panduan Penilaian Kesetaraan Taraf Amalan Perkilangan Baik (APB) Pengilang TMHS Luar Negara, Edisi Pertama, September 2024
published on 2024-08-30
|
Progestogens (Cyproterone Acetate, Medroxyprogesterone Acetate, Chlormadinone): Risk of Meningioma
published on 2024-08-25
|
[Updated August 2024] Product Classification Form - NPRA/413/01-3
published on 2024-08-20
|
Pengemaskinian Drug Registration Guidance Document (DRGD) Berkaitan Keperluan Deklarasi Bahan Bersumberkan Haiwan Pada Label Produk
published on 2024-08-14
|
Azacitidine (Injectable Formulation): Risk of Cutaneous Vasculitis
published on 2024-08-12
|
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
|
Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Eighth Revision July 2024
published on 2024-07-23
|
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
|
Hydroxychloroquine: Risk of Sweet’s Syndrome (Acute Febrile Neutrophilic Dermatosis)
published on 2024-07-15
|
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
|
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
|
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
|
Anti-Clusters of Differentiation 20 (CD20) Antibodies (Rituximab, Obinutuzumab, Ofatumumab, Ocrelizumab): Risk of Pyoderma Gangrenosum
published on 2024-06-28
|
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
|
Garis Panduan Persediaan Pemeriksaan APB Bagi Pengilang Pengilang Tradisional, Suplemen Kesihatan dan Kosmetik, Edisi Keempat, Jun 2024
published on 2024-05-31
|
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
|
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
|
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
|
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
|
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
|
Guidelines for Clinical Trial
published on 2024-03-20
|
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
|
Domperidone: Risk of Psychiatric Withdrawal Events When Used Off-Label for Lactation Stimulation
published on 2024-03-12
|
Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2023
published on 2024-03-11
|
[Updated] Metformin: Risk of Vitamin B12 Deficiency
published on 2024-03-04
|
Direktif berkenaan pelaksanaan Electronic Labelling (e-Labelling) ke atas produk farmaseutikal di Malaysia
published on 2024-02-22
|
Direktif berkenaan pindaan kepada proses meluluskan permohonan Lesen Import Percubaan Klinikal (CTIL) dan Kebenaran Untuk Mengilang Produk Tidak Berdaftar Untuk Tujuan Percubaan Klinikal (CTX) yang melibatkan kajian klinikal First-in-Human (FIH).
published on 2024-02-20
|
Direktif Berkenaan Pengemaskinian dan Pelaksanaan Guideline for Facilitated Registration Pathway (FRP), Revision 1, 2023
published on 2024-02-19
|
Pekeliling Berkenaan Pengemaskinian Guidance Document and Guidelines for Registration of Biosimilars in Malaysia
published on 2024-02-19
|
Guidance Document and Guidelines for Registration of Biosimilars in Malaysia
published on 2024-02-19
|
Guideline For Facilitated Registration Pathway (FRP)
published on 2024-02-17
|
Statins (Atorvastatin, Rosuvastatin, Simvastatin): Interaction with Ticagrelor Leading to Increased Risk of Rhabdomyolysis
published on 2024-02-15
|
Keputusan Mesyuarat Pihak Berkuasa Kawalan Dadah Kali Ke-393
published on 2024-02-09
|
Rejection of BE Studies Conducted at the BE Centre Synapse Labs Pvt. Ltd., India following Inspection Findings by The European Medicines Agency (EMA)
published on 2024-01-23
|
Makluman Pengemaskinian Tempoh Jangka Hayat Vaksin COVID-19 iaitu CoronaVac Daripada 30 Bulan Kepada 36 Bulan
published on 2024-01-23
|
Penolakan Kajian Bioekuivalens (BE) yang Dijalankan oleh Pusat Kajian BE Synapse Labs Pvt. Ltd. Susulan Penemuan Pemeriksaan European Medicines Agency (EMA)
published on 2024-01-23
|
Imatinib: Risk of Thrombotic Microangiopathy
published on 2024-01-22
|
PEKELILING BIL 1/2024 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA
published on 2024-01-19
|
Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Seventh Revision January 2024
published on 2024-01-19
|
Rivastigmine: Risks of QT Prolongation and Torsade de Pointes
published on 2024-01-19
|
Pekeliling berkenaan pengemaskinian syarat pendaftaran midazolam dalam Drug Registration Guidance Document (DRGD)
published on 2024-01-18
|
Direktif untuk semua produk yang mengandungi rivastigmine: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) dengan maklumat keselamatan berkaitan risiko QT prolongation dan Torsade de Pointes (TdP)
published on 2024-01-18
|
Direktif untuk semua produk yang mengandungi imatinib: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) dengan maklumat keselamatan berkaitan risiko thrombotic microangiopathy (TMA)
published on 2024-01-18
|
Direktif untuk semua produk yang mengandungi metformin (termasuk produk kombinasi): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) bagi memperkukuhkan maklumat keselamatan berkaitan risiko kekurangan vitamin B12 (vitamin B12 deficiency)
published on 2024-01-17
|
New Drug Products (NCE)
published on 2023-12-26
|
DCA News
published on 2023-12-20
|
Pekeliling Berkenaan Pengemaskinian Guidance Document and Guidelines for Registration of Biosimilars in Malaysia
published on 2023-12-18
|
Clomiphene: Risk of Serious Visual Disturbances Potentially Leading to Blindness
published on 2023-12-01
|
Ibrutinib (IMBRUVICA®): Package Insert Updates to Dose Modifications for Adverse Reactions and to Special Warnings and Precautions for Use
published on 2023-11-29
|
[Updated] Loperamide: Risk of Acute Pancreatitis
published on 2023-11-29
|
[Updated] Topiramate: Neurodevelopmental Disorders in Children Exposed to Topiramate during Pregnancy
published on 2023-11-28
|
Thanks for Joining #MedSafetyWeek 2023 💖
published on 2023-11-11
|
Hi! Are You a Nurse? 🏥
published on 2023-11-10
|
Approved Clinical Trial Import License & Clinical Trial Exemption (CTX) Application
published on 2023-11-10
|
Hey, Are You a Doctor? 👨⚕️🏥👩⚕️
published on 2023-11-09
|
Concerned About Side Effects? Remember to check 👀 , talk 🗣 , and tell 💬 this #MedSafetyWeek!
published on 2023-11-08
|
💊 Medications in Malaysia are Continually Monitored to Ensure Their Safety 🔎
published on 2023-11-07
|
Sleep Troubles After Medication 😵? Remember to Report Them 📝
published on 2023-11-06
|
Unexpected Side Effects Can Happen Anywhere, at Any Time: Your Report, Patients' Safety 💊
published on 2023-11-06
|
📣 #MedSafetyWeek kicks off today!
published on 2023-11-05
|
Preparations for #MedSafetyWeek are well underway – are you ready?
published on 2023-11-03
|
Get Ready for #MedSafetyWeek 2023!
published on 2023-11-01
|
Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Sixth Revision October 2023
published on 2023-10-24
|
Isotretinoin: Risk of Psychiatric Disorders and Sexual Dysfunction
published on 2023-10-13
|
Direktif untuk semua produk yang mengandungi topiramate: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko gangguan neurodevelopmental dalam kalangan kanak-kanak yang terdedah kepada topiramate semasa kehamilan ibu dan menyelaraskan maklumat keselamatan berkenaan risiko kecacatan kongenital (congenital malformation)
published on 2023-10-13
|
Direktif untuk semua produk yang mengandungi loperamide : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko pankreatitis akut (acute pancreatitis)
published on 2023-10-13
|
Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2022
published on 2023-09-08
|
Cephalosporins: Risk of Seizures
published on 2023-09-05
|
Valaciclovir: Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
published on 2023-08-23
|
[Updated] Clindamycin (Systemic): Risk of Acute Kidney Injury
published on 2023-08-07
|
