Official Malaysian Government Website
Newsroom
868 items
Announcements, product safety communications and regulatory updates.
Untuk Makluman, Kaunter Unit Hasil akan ditutup bermula dari 29 Disember 2016 sehingga 3 Januari 2017 berikutan penutupan akaun utama. Sebarang Bayaran di Kaunter tidak diterima untuk tempoh ini…
Download Press Release in PDF
Document attached
Download Press Release in PDF
Document attached
Untuk makluman, Seksyen ICT, NPRA telah memuatnaik Manual Pengguna QUEST3+ di Portal NPRA. Maklumbalas dan cadangan daripada penguji adalah dialu-alukan dan boleh dihantar melalui emel kepada…
Document attached
MOPI International Good Manufacturing Practice Training Program 2017 Training Venue:THE BOULEVARDSt Giles Premier HotelHotel Address | Mid Valley City |Lingkaran Syed Putra | 59200 |Kuala Lumpur |…
Document attached
Laporan Tahunan NPRA 2016 DOWNLOAD PDF
Document attached
ASEAN Common Technical Dossier (ACTD) Preparation: Generic Products for Malaysian Submission 5 December 2016 (Monday) Venue OLIVE TREE HOTELBayan Lepas, Penang Time8.30 am – 5.00 pm Who should attend…
Document attached
Date: 14 November 2016 Description: There have been post-marketing reports of etonogestrel implants (non-radiopaque and radiopaque) found in the vasculature (including the pulmonary artery) and the…
Date: 25 August 2016 Description: Tarceva® (erlotinib) is no longer indicated for the first-line maintenance treatment in patients without an epidermal growth factor receptor (EGFR)-activating…
Download in PDF
Document attached
Download Article in PDF
Document attached
DATE: 26 Oct 2016 (Wednesday) TIME: 9.30am-3 .30pm VENUE: Hotel Royale Chulan Damansara SPEAKERS: From the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia. OBJECTIVES: •…
Document attached
Download Full Document
Document attached
Date: 1 July 2016 Description: Tarceva® (erlotinib) is no longer indicated for the first-line maintenance treatment in patients without an epidermal growth factor receptor (EGFR)-activating mutation…
Date: 22 July 2016 Description: Adempas® (riociguat) should not be used in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP). Riociguat is not approved…
Download Full Document
Document attached
Sukacita dimaklumkan bahawa sistem aplikasi QUEST3+ (modul kosmetik notifikasi) akan dilancarkan pada 1 Ogos 2016 (Isnin). Tarikh pelancaran “modul pendaftaran produk” bagi produk farmaseutikal akan…
Document attached
PENGUMUMAN GANGGUAN TALIAN TELEFON UTAMA NPRA Adalah dimaklumkan bahawa talian telefon utama NPRA 03-78835400 tidak dapat berfungsi buat masa ini. Semua panggilan masuk ke NPRA adalah dikehendaki…
Document attached
Nama untuk penerima pada bank draf / kiriman wang / wang pos masih dikekalkan di bawah nama BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN sehingga diberitahu pada masa akan datang.
1. Penangguhan Pelancaran QUEST3+ Seperti yang dimaklumkan sebelum ini, QUEST3+ akan dilancarkan pada 1 Julai 2016 nanti. Namun begitu, pihak BPFK terpaksa menunda tarikh pelancaran Quest3+ kerana…
1. Penangguhan Pelancaran QUEST3+ Seperti yang dimaklumkan sebelum ini, QUEST3+ akan dilancarkan pada 1 Julai 2016 nanti. Namun begitu, pihak BPFK terpaksa menunda tarikh pelancaran Quest3+ kerana…
Date: 18 May 2016 Description: Locabiotal® Solution (oromucosal/nasal spray containing fusafungine) will no longer be available in Malaysia and worldwide following a review which concluded that the…
Date: 25 April 2016 Description: A Direct Healthcare Professional Communication (DHPC) has been approved by NPCB to inform healthcare professionals of the risk of HBV reactivation in patients who are…
Date: 30 March 2016 Description: The package inserts of Xalkori® will be updated with safety information on the risk of cardiac failure following a safety review of clinical trial data and…
