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Announcements, product safety communications and regulatory updates.
Date: 3 March 2016 Description: Postmarketing reports have been received of hepatic decompensation and hepatic failure in patients treated with Viekirax® with Exviera®, including cases involving…
Date: 4 February 2016 Description: Cases of clinically significant hypercalcaemia have been reported weeks to months following discontinuation of denosumab treatment in patients with growing…
LATIHAN PENDIDIKAN 2016 Latihan ISPE TMHS & Kosmetik 2.0 Tarikh : 9 & 10 Ogos 2016 (Selasa dan Rabu) Masa : 8.30 pagi – 5.00 petang Lokasi Qliq Damansara No.2, Jalan PJU 8/8A, Damansara Perdana…
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PERINGATAN: Tarikh perlaksanaan kawalan regulatori API untuk permohonan baru produk generik yang mengandungi Racun Berjadual bagi produk dalam bentuk dos oral berkuatkuasa 1 JULAI 2016 Direktif…
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Click the download button below to download the full presentation slides. Presentation Slides for QUEST3+ Industry Briefing FAQ for QUEST3+ Industry Briefing Download Download Presentation Slides for…
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Format_Laporan_Tindakan_Pembetulan_Pencegahan_CAPA_Nota_Penerangan_CAPA.pdf Visit CAPA section for more information.
Objektif Mengukuhkan kesedaran industri mengenai kepentingan Pengurusan Tindakan Pembetulan dan Pencegahan (CAPA) dalam meningkatkan pematuhan APB Berkongsi isu-isu APB semasa bagi pengilang TMHS dan…
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KENYATAAN AKHBAR KAWALAN KOSMETIK DI MALAYSIA 1. Produk kosmetik ditakrifkan sebagai ‘bahan atau persediaan untuk digunakan pada bahagian luaran tubuh badan manusia dan berfungsi untuk membersih…
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KENYATAAN AKHBAR PENGGUNA DINASIHATKAN UNTUK MENGELAKKAN DARI MENGGUNA PRODUK KOSMETIK YANG DIKESAN MENGANDUNGI RACUN BERJADUAL Orang awam dinasihatkan untuk mengelakkan daripada membeli dan mengguna…
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Who should attend? Logistics /Supply Chain Professionals; Transporters; Manufacturing Professionals; QC / QA Professionals; and also of interest to: Consultants; Operations Managers, Operational Risk…
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Download/view Direktif Perluasan Skop Pelaksanaan Kawalan Regulatori Ke Atas Bahan Aktif Farmaseutikal Bagi Produk Generik Yang Mengandungi Racun Berjadual (Fasa II).
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Date: 14 December 2015 Description: New contraindications have been added to the prescribing information for Cellcept® (mycophenolate mofetil) related to the teratogenic risk. Cellcept® is…
List of Cosmetic Manufacturer in Malaysia that conforms to the requirement of Good Manufacturing Practices (GMP) in accordance to the ASEAN Guideline for Cosmetic Good Manufacturing Practice is…
PERINTAH CUKAI BARANG DAN PERKHIDMATAN (PEMBEKALAN BERKADAR SIFAR) (PINDAAN) (NO.2) 2015 Menurut Perintah Cukai Barang dan Perkhidmatan (Pembekalan Berkadar Sifar) (Pindaan) (No. 2) 2015, semua Ubat…
The course training program consists of 9 principal modules and 6 additional modules, each of 3 days duration. These modules cover the essential principles of Good Manufacturing Practice (GMP)…
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Panduan Bayaran Yuran Vaccine Lot Release and Slaid Pembentangan Taklimat Yuran (23 Nov 2015) are now available for download at Guidelines Central. Slaid_Pembentangan_Taklimat_Yuran_23_Nov_2015.pdf…
Click to download REAKSI September 2015, No.25. Hydroxyzine: Risk of Effects on Heart Rhythm Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors: Possible Risk of Diabetic Ketoacidosis For other…
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Online ADR reporting for Healthcare Professionals will be temporarily unavailable due to database upgrading from 9/12/2015 until further notice. During this period, please download the manual ADR…
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