DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)1. INTRODUCTION1.1. A significant part of the quality of a finished pharmaceutical product isdependent on the quality of the Active Pharmaceutical ingredients (APIs)used for its formulation. Thus, a proper system of qualification of suppliers isnecessary to ensure a constant sourcing of APIs of appropriate quality andto safeguard the public health interests. This will be done throughstandardized quality assessment and inspection procedures.1.2. The National Pharmaceutical Control Bureau (NPCB) under the purview ofthe Ministry of Health Malaysia will introduce mandatory control of APIs aspart of the requirements in the product registration application. This will beimplemented prospectively according to a phased timeline established bythe NPCB.1.3. The implementation will begin with voluntary submission for New ChemicalEntities in April 2011 and followed by;Phase 1 - New Chemical Entity (mandatory in Jan 2012)Phase 2 - Scheduled Poison, (to be determined)Phase 3 - Non-scheduled Poison (to be determined)1.4. The procedure for control of APIs established by the NPCB is based on thefollowing principles:A general understanding of the production and quality control activities ofthe manufacturer;Assessment of API data and information, including changes andvariations, submitted by the product registration holder (PRH)/ APImanufacturer. These data should include the manufacturing process,material specifications and test data and results;Assessment of the manufacturing site(s) for consistency in productionand quality control of raw materials, with specific emphasis on key rawmaterials and APIs during and after purification through compliance withGood Manufacturing Practice (GMP);Random sampling and testing of APIs (post-marketing surveillance);Handling of complaints and recalls; andMonitoring of complaints from other agencies and countries.1.5. This guideline is intended to provide guidance regarding the requirements tobe included for APIs in the quality part of the product dossier.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 310
Drug Registration Guidance Document (<strong>DRGD</strong>)2. DEFINITION2.1 DEFINITION OF ACTIVE PHARMACEUTICAL INGREDIENT (API)Any substance or mixture of substances intended to be used in themanufacture of a pharmaceutical dosage form and that, when used so,becomes an active ingredient of that pharmaceutical dosage form. Suchsubstances are intended to furnish pharmacological activity or otherdirect effect in the diagnosis, cure, mitigation, treatment or prevention ofdisease or to affect the structure and function of the body (WHOTechnical Report Series No.970,2012).2.2 CLASSIFICATION OF ACTIVE PHARMACEUTICAL INGREDIENT (API)API classification can be divided into:Inorganic substances;Organic substances (isolated from materials of animal or humanorigin); andOrganic substances (synthetic or semi-synthetic or isolated fromherbal sources or micro-organisms).3. SCOPE3.1. This Guideline encompasses the APIs of new products for registration. Thisis applicable to all pharmaceutical products (excluding traditional products,veterinary products, and health supplement products) both locallymanufactured and imported.3.2. Biological active substances and immunological active substances areexcluded from the scope of this Guideline.3.3. APIs used in products for export only (FEO) are exempted from therequirement for submission of the Drug Master File (DMF) and Certificationof Suitability (CEP) in the product application.3.4. The DMF and CEP are only applicable for final APIs and not APIintermediates.3.5. Separate registration of the APIs is not a requirement for the purpose ofproduct registration. However, the required technical documentationNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 311
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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