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Biologic Definition & Introduction. (a) The term ‘biopharmaceutical' was coined in the 80's to define proteins that were made by recombinant DNA technology, which includes hybridoma technology for monoclonal antibody (mAb) production. (b) Biologic/ biological product refers to a product whose active substance is made by or derived from a ...
Aug 1, 2018 · 01 August 2018. Hits: 24413. Document Name. Download. Updated. Garispanduan Pelaksanaan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) DOWNLOAD. January 2020.
FOOD PRODUCTS THAT ARE NOT CATEGORIZED AS FDI PRODUCTS AND REGULATED BY FSQD INCLUDE : 1. 100% food ingredients. 2. Food products with or without active ingredients ( eg; herbs, vitamins, minerals, etc) as below: i) Instant drink products containing sugar and creamer (e.g. premix coffee, tea, chocolate, soy, cereal).
The NPRA reserves the right to amend any part of the guideline whenever it deems fit. Any enquiry on nitrosamine impurities may be submitted to: National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia, Lot 36, Jalan Profesor Diraja Ungku Aziz (Jalan Universiti), 46200 Petaling Jaya, Selangor, Malaysia. (e-mail: npra@npra.gov.my)
Oct 13, 2021 · Posted By Ng Pei Ling. Variation application for pharmaceutical products shall be done according to the Malaysian Variation Guideline (MVG). For unregulated drug substances, kindly note that only the following sections are required and will depend on the type of variation being applied. This is applicable until further notice: Applicant shall ...
The scope of this guideline applies to new drug products, generic medicines and biologics including cell and gene therapy products (CGTPs). The final decision for a product to be considered via FRP is subject to NPRA discretion. NPRA may decide based on the eligibility criteria stated in this guideline, which may include risk-benefit
Sep 30, 2018 · Guidance and Requirements on Conditional Registration of Pharmaceutical Products During Disaster 2022-03-15. 2021. Variation Application For Pharmaceutical Products- Malaysian Variation Guideline (MVG) 2021-10-13. Malaysian Guidelines on Good Pharmacovigilance Pratices (GVP) for Product Registration Holders (1st Edition, August 2021) 2021-09-30.
