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National Pharmaceutical Regulatory Agency (NPRA) Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia. Phone: +603-7883 5400
Jul 2, 2015 · The National Pharmaceutical Regulatory Agency (NPRA), formerly known as the National Pharmaceutical Control Bureau (NPCB), was set up in October 1978 under the quality control activity of Pharmacy and Supply Programme. This institution was established to implement quality control on pharmaceutical products.
Product name shall consist of dosage form and strength (for single active ingredient product). (e.g.XYZ Capsule 500mg) Any product name which is the same or similar either in writing/ pronunciation, with the product name of an adulterated product is prohibited. Product name may be included together with the brand name or trademark name, if ...
Information from other available registered products in Malaysia. A1 - A3. Details of the following as entered under Product Validation will appear automatically in the application form: 1. Product name; 2. Name and Strength of Active Ingredients, Name and Strength of Excipients; and. 3. Dosage form.
Sep 7, 2018 · Template for Declaration of Worldwide Registration Status (WWRS) E15. -. Download. 3/2023. Borang Permohonan Sijil Indikasi / Sijil Deklarasi. Download. Download. 4/2023. Screening Checklist for Generics Application.
Section C: Body of Data. To attach the Print Form (Section P – Product Information) once all the documents are completed prior to submission. P1 : Description & Composition of Finished Product. P2 : Pharmaceutical Development. P2.1 : Information on Development Studies. P2.2 : Components of the Drug Product. P2.3 : Finished Products.
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 ...
