DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCEAddition of the paragraph and link:12.1 FOREIGN GMP INSPECTIONPRH must provide acceptable evidence to show that themanufacturer of the product follows an internationally acceptedstandard of Good Manufacturing Practice (GMP) andrecognized by the Authority in Malaysia.4.March2013Section D:Inspection &LicensingThe Control of Drugs and Cosmetics Regulations 1984 (CDCR)requires that the standard of manufacture and quality control ofmedicinal products manufactured outside Malaysia is taken intoconsideration before the products are registered with theAuthority. NPCB as the secretariat to the DCA is responsible toensure all manufacturers of registered products in Malaysia areable to provide acceptable evidence that the manufacturingpremises conform to current GMP requirements. Hence, foreignmanufacturers are also subjected to GMP conformityassessments through acceptable GMP evidence or GMPinspection.Premises InspectionEvaluation Committee No.3/2013, 14 March 2013For details and forms, please refer Guidance Document onForeign GMP Inspection.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 488