Pekeliling pemeriksaan Amalan Perkilangan Baik (APB) bagi Pengilang di Luar Negara (Bil (40) dlm. BPFK/PPP/01/03) Direktif untuk semua produk yang mengandungi isoniazid: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan berkaitan risiko pancreatitis.

The product / cosmetic under NPRA regulatory control status is subjected to changes according to regulatory update / needs. Produk / kosmetik di bawah status kawalan kawal selia NPRA tertakluk kepada perubahan mengikut kemas kini peraturan / keperluan.

Nov 14, 2018 · Bahagian Regulatori Farmasi Negara (NPRA), atau dikenali sebagai Biro Pengawalan Farmaseutikal Kebangsaan (BPFK), telah ditubuhkan pada Oktober 1978 dibawah aktiviti kawalan kualiti program farmasi dan bekalan.

QUEST 3+ Online Submission System enabled Product License Holder, Manufacturer, Importer, Re-packer, Reseller and other related users to conduct secured online transactions for product registration, variation, licensing, market sampling, renewal and other transactions. © Copyright 2015-2025 NPRA. All Rights Reserved. | Disclaimer.

Mar 27, 2025 · Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia. Product Classification, QUEST3+ System Basic, ASEAN Guidance Documents, Guideline For The Submission Of Product Samples For Laboratory Testing & Clinical Trials. Regulation Basic.

The status of licensed premise under NPRA regulatory control is subjected to changes according to stipulated requirements / regulatory updates. Status premis berlesen di bawah kawal selia NPRA adalah tertakluk kepada keperluan peraturan / regulatori terkini yang ditetapkan.

BPFK Malaysia relationship started 30+ years ago, in registering products ranging from product gazetting into the food act to supplement (MAL), traditional (MAL), cosmetics (NOT) and food products registrations. BPFK is also known as NPRA.

LKEY Consultancy was founded in 2016 to help clients interact with National Pharmaceutical Regulatory Agency, NPRA (Formerly known as National Pharmaceutical Control Bureau), and Ministry of Health Malaysia.

Misi NPRA adalah menjamin kesihatan rakyat melalui kawalan regulatori ubat-ubatan dan kosmetik berlandaskan kecemerlangan saintifik. ConSERF, Pelaporan Kesan Advers AEFI, RiMUP, Pembatalan Produk dan lain- lain. Amaran Keselamatan, Pelaporan ADR, MADRAC, Aduan Produk dan Penerbitan.

GMP Certificate has 3 years validity from the latest GMP Inspection date (2 years for inspection conducted via desktop inspection). If you have any queries regarding the validity of the certificate issued, please contact [email protected]. Results from the search does not include GMP certificate number with an alphabetical suffix.