DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)1.2 PROCESSING AND ANALYSIS FEE FOR PRODUCT REGISTRATIONEvery application for registration shall be accompanied with a processing andanalysis fee, as specified below (effective 1 st January 2007):No.Category ofProduct* ProcessingFeesAnalysis FeesTotal FeesPharmaceuticalSingle active ingredient :RM 3,000.00RM 4,000.001.a) New DrugProductsRM 1,000.00b) BiologicsTwo or more active ingredients :RM 4,000.00RM 5,000.00Pharmaceuticala) Generic(ScheduledPoison)Single active ingredient :RM 1,200.00RM 2,200.002.b) Generic(Non-ScheduledPoison)c) HealthsupplementRM 1,000.00Two or more active ingredients:RM 2,000.00RM 3,000.003. Natural Product RM 500.00 RM 700.00 RM 1,200.00* As stipulated in the CDCR 1984, Regulation 8.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 132
Drug Registration Guidance Document (DRGD)1.3 CHARGES FOR APPLICATION OF LICENSES1.3.1 Before a product is registered, the applicant shall apply for a manufacturerlicense. The processing fee is as specified below:License Processing fee Timeline Validity1. Manufacturer RM 1,000.00 Not more than 1 month 1 year1.3.2 After a product is registered, the applicant shall apply for an import/ wholesalelicense. The processing fees are as specified below:License Processing fee Timeline Validity1. Import RM 500.00 Not more than 1 month 1 year2. Wholesale RM 500.00 Not more than 1 month 1 year1.4 CHARGES FOR AMENDMENTS TO PARTICULARS OF AREGISTERED PRODUCTTypes of AmendmentPharmaceuticalProcessing feeNatural Product1. Change of Manufacturing Site(Type II, III, IV, V)RM 1,000.00 RM 500.002. Change of Product Registration Holder RM 1,000.00 RM 500.00National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 133
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PART III: NON-CLINICAL DATADrug Reg
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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