Directives Biologics
Direktif Untuk Melaksanakan Malaysian Variation Guideline For Biologics (MVGB)
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Publications and guidelines
669 publications
Guidance documents, forms, circulars and reports issued by the Authority.
Directives
Direktif Keperluan Sijil Analisa Produk Siap (Certificate of Analysis (COA) For Finished Product) Semasa Permohonan Pendaftaran Baru Produk Semulajadi dan Produk Suplemen Kesihatan dengan General Claims
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Directives
Direktif Bagi Semua Produk Yang Mengandungi Interferon Alfa dan Interferon Beta dengan Maklumat Keselamatan Berkaitan Risiko Kesan Advers Pulmonary Arterial Hypertension (PAH)
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REAKSI Drug Safety News
New Publication: Reaksi Drug Safety News - January 2017
REAKSI Drug Safety News, No. 33, January 2017 Eylea ® vs. Zaltrap ® (aflibercept):Same Active Ingredient,Different Safety Profiles? DOWNLOAD PDF
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Circulars
Pekeliling Berkenaan Keperluan Untuk Mengemaskini Memuat Naik Label Produk Kosmetik Pada Sistem Quest3+
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Directives - Cosmetic
Pekeliling Tindakan Punitif Regulatori Ke Atas Syarikat Pemegang Notifikasi Kosmetik Yang Gagal Dihubungi Oleh Agensi Regulatori Farmasi Negara (NPRA)
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Circulars
Pekeliling Untuk Memaklumkan Status Kemaskini Bahan-Bahan Dalam Annexes Pada Guidelines For Control Of Cosmetic Products In Malaysia
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MADRAC Bulletin
Announcement: “New Publication: Bulletin MADRAC - August 2016”
MADRAC Bulletin - August 2016 Annual Report for 2015 ▪ Spontaneous Adverse Drug Reactions (ADRs) including Adverse Events Following Immunisation (AEFIs) Reported in Malaysia Regulatory Matters ▪…
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Directives
Direktif bagi semua produk yang mengandungi olanzapine dengan maklumat keselamatan berkaitan kesan advers Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
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Directives
Direktif Mengenai Keperluan Sijil Amalan Perkilangan Baik (APB) Untuk Produk Kajian Farmaseutikal Bagi Tujuan Permohonan Lesen Import Percubaan Klinikal (LIPK)
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REAKSI Drug Safety News
New Publication: Reaksi Drug Safety News - September 2016
REAKSI Drug Safety News, No. 31, September 2016 Live Attenuated Vaccines: Reminder to Avoid Use In Immunosuppressed Individuals DOWNLOAD PDF
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Circulars
Pekeliling Pendaftaran Semula Bersyarat Bagi Produk Generik Berdaftar Yang Masih Belum Memenuhi Keperluan Kajian Bioekuivalens (BE) Semasa Proses Pendaftaran Semula Dan Produk Generik Yang Telah Digantung Pendaftaran Kerana Penilaian Laporan Kajian BE Did
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Directives
Direktif bagi Semua Produk yang Mengandungi Sodium Valproate bagi Memperkukuhkan Amaran Berkaitan Risiko Abnormal Pregnancy Outcomes
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Directives
Direktif bagi Semua Produk yang Mengandungi Codeine dengan Maklumat Keselamatan Berkaitan Risiko Kesan Advers Respiratory Depression
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Directives
Direktif bagi Semua Produk yang Mengandungi Warfarin Dengan Risiko Kesan Advers Calciphylaxis
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REAKSI Drug Safety News
New Publication: Reaksi Drug Safety News - July 2016
REAKSI Drug Safety News, No. 30 ,July 2016 Concomitant Use of Spironolactone and Renin-Angiotensin System Drugs in Heart Failure: Risk of Potentially Fatal Hyperkalaemia Noxafil® (posaconazole)…
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REAKSI Drug Safety News
New Publication: Reaksi Drug Safety News - May 2016
REAKSI Drug Safety News, No. 29 ,May 2016 Apomorphine with Domperidone: Minimising the Risk of Cardiac Side Effects Locabiotal® Solution (fusafungine): Withdrawal of Registration and Product Recall…
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Circulars
Lanjutan Tempoh Masa Untuk Meletakkan Huruf “Z” Pada Nombor Pendaftaran Ubat-Ubatan Berkadar Sifar
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MADRAC Bulletin
New Publication: Bulletin MADRAC - April 2016
Bulletin MADRAC April 2016 Welcoming the new MADRAC members (2016-2018) Pharmacogenomics in Determining Drug Response Azithromycin: Risk of QT Prolongation and DRESS Mycophenolate: Important New…
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Circulars
Makluman Pelaksanaan Yuran Aktiviti Plasma Product Lot Release yang Dijalankan Oleh Agensi Regulatori Farmasi Negara (NPRA), Kementerian Kesihatan Malaysia (KKM)
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Directives
Direktif Untuk Penggunaan Drug Registration Guidance Document Second Edition September 2016
Drug Registration Guideline Document DRGD 2016 Page Download Full Document
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FAQ Quest3+
B2B Online Payment Transaction Flow
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Directives Traditional
Direktif Untuk Melaksanakan Malaysian Variation Guideline for Natural (Traditional Medicine & Homeopathy) and Health Supplement Products (Abridged Evaluation)
Document Name Updated Direktif Untuk Melaksanakan Malaysian Variation Guideline for Natural (Traditional Medicine & Homeopathy) and Health Supplement Products (Abridged Evaluation) Jul 2016 Malaysian…
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Directives
Direktif bagi Semua Produk yang Mengandungi Bahan Aktif Minyak Cajeput (Melaleuca Leucadendra) dalam Bentuk Dos Topikal dengan Menambah Kenyataan Amaran Berkaitan Risiko Masalah Pernafasan/ Kesukaran Bernafas
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REAKSI Drug Safety News
New Publication: REAKSI Drug Safety News Mac 2016
Click to download REAKSI Mac 2016, No.28. Proton Pump Inhibitors (PPIs): Potential Long-term Safety Issues Paliperidone Palmitate (Invega Sustenna®): Alert on Potential Serious Adverse Events For…
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