Circulars
Pekeliling Untuk Memaklumkan Status Kemaskini Bahan-Bahan Dalam Annexes Pada “Guidelines For Control Of Cosmetic Products In Malaysia”
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Resources
Publications and guidelines
669 publications
Guidance documents, forms, circulars and reports issued by the Authority.
REAKSI Drug Safety News
New Publication: REAKSI Drug Safety News July 2015
Click to download REAKSI July 2015, No.24. Patent Ductus Arteriosus (PDA) Closure: Indomethacin vs. Ibuprofen – An Overview of the Local Drug Safety Profiles For other issues of REAKSI Drug Safety…
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Directives
Direktif untuk semua produk yang mengandungi montelukast: pengemaskinian sisip bungkusan dengan maklumat kesan advers berkaitan thrombocytopenia
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Directives
Direktif untuk semua produk yang mengandungi diclofenac (formulasi sistemik) : pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan kesan advers kardiovaskular
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MADRAC Bulletin
MADRAC Bulletin April 2015
Click to view/download the MADRAC Bulletin April 2015. Visit Newsletter: MADRAC Bulletin for other issues of MADRAC Bulletin.
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MADRAC Bulletin
MADRAC Bulletin December 2014
Click here to view/download the MADRAC Bulletin December 2014.
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REAKSI Drug Safety News
REAKSI Drug Safety News January 2014
Date : 22 May 2014 Ccategory : Other News and Important Annoucement Click here for REAKSI Drug Safety News January 2014.
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MADRAC Bulletin
"New Publication : MADRAC Bulletin August 2013"
Date : 25 June 2014 Category : Other News and Important Annoucements. Click here to download the full document.
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MADRAC Bulletin
"New Publication : MADRAC Bulletin December 2013"
Date : 07 July 2014 Category : Other News and Important Annoucement Click here to download the full document.
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MADRAC Bulletin
“New Publication: MADRAC Bulletin April 2014”
Date: 30 July 2014 Click here to download the full document.
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MADRAC Bulletin
New Publication: MADRAC Bulletin August 2014
Date: 27 November 2014 Click here to download the full document.
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NPBC Annual Report / Archive
Annual Report 2009 (English) Annual Report 2009 (BM) Annual Report 2008 Annual Report 2007 Annual Report 2006 Annual Report 2004 Annual Report 2003 Annual Report 2002 Annual Report 2001 Annual Report…
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Newsletter: Berita Ubat-ubatan / Archives
Year Issues 2012 April August December 2011 March June September December 2010 March June September December 2009 March June September December 2008 March June September December 2007 March June…
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Newsletter: MADRAC Bulletin / Archives
No Document Name Type Size 15. MADRAC Newsletter 2009 - December - Potential Medication Errors with Tamiflu for Oral Suspension- Update on Oseltamivir ADRs- Early Communication about an Ongoing…
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Reporting by Healthcare Professional
If you think you may be experiencing an adverse event caused by a medicine or medical device, seek advice from your doctor / pharmacist as soon as possible. Reporting Adverse Drug Reactions Guide for…
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New Drug Products (NCE)
New Drug Products (NCE) 2025 New Drug Products (NCE) 2024 New Drug Products (NCE) 2023 New Drug Products 2022 New Drug Products 2021 New Chemical Entities 2020 New Chemical Entities 2019 New Chemical…
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REAKSI Drug Safety News (Berita Keselamatan Ubat REAKSI)
Note: From 2018 onwards, there will be no new publications of the REAKSI Newsletter. For the most recent safety issues regarding medicine use, please refer to Safety Alerts for Healthcare…
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Laporan Tahunan Pusat Pemonitoran Kesan Advers Ubat
Laporan Tahunan Pusat Pemonitoran Kesan Adverse Ubat 2016 Laporan Tahunan Pusat Pemonitoran Kesan Adverse Ubat 2015 Laporan Tahunan Pusat Pemonitoran Kesan Adverse Ubat 2014 Laporan Tahunan Pusat…
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Newsletter: MADRAC Bulletin
The MADRAC Bulletin provides information on the activities of the Malaysian Adverse Drug Reactions Advisory Committee, which meets bimonthly and advises the Drug Control Authority (DCA) on local and…
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Newsletter: Berita Ubat-ubatan (Buletin: Berita Ubat-ubatan)
Year Edition 2019 April September 2018 March June December 2017 March June September Disember 2016 April August December 2015 April August 2014 April August December 2013 April August December 2012…
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Pelaporan Kesan Sampingan Ubat atau Vaksin Untuk Pengguna
Jika anda mengesyaki anda mengalami kesan sampingan ubat atau vaksin, dapatkan nasihat doktor atau ahli farmasi secepat mungkin. Pelaporan Kesan Sampingan Ubat atau Vaksin untuk Pengguna (Nota: Jika…
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Directives
DIREKTIF PENGUATKUASAAN KEPERLUAN KAJIAN BIOEKUIVALENS (BE) BAGI PRODUK GENERIK DALAM BENTUK DOS ORAL TABLET/KAPSUL YANG BERSIFAT EFFERVESCENT, DISPERSIBLE, ORODISPERSIBLE, SUBLINGUAL, BUCCAL DAN CHEWABLE YANG MENGANDUNGI BAHAN AKTIF RACUN BERJADUAL
Date: 23 February 2015 Description: Click here to download the full document.
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Directives Veterinary
Direktif Guideline on GMP for Veterinary Premixes (January 2015)
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Directives
Direktif untuk semua produk Metoclopramide: Memperketatkan Indikasi Dan Mengehadkan Dos Penggunaan Berikutan Risiko Kesan Advers Neurologik
Date: 08 January 2015 Description: Click here to download the document.
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Directives
Keperluan Ahli Farmasi Berdaftar Sepenuh Masa untuk Mengetuai Bahagian Pengeluaran Premis Pengilang Produk Farmaseutikal, Radio Farmaseutikal dan Veterinar yang Berdaftar dengan Pihak Berkuasa Kawalan Dadah (PBKD) : Perlanjutan Tarikh Perlaksanaan
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