DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 314
Drug Registration Guidance Document (<strong>DRGD</strong>)pertaining to each API should be submitted with the new online productregistration application.3.6. Assessment of an API will be performed once submission of an applicationfor registration of a product using the said API is made by a ProductRegistration Holder.4. PROCEDURE FOR SUBMISSION4.1 HOW TO SUBMIT4.1.1 The PRH of the product registration shall submit Part 2.S ACTD aspart of product application. Where any information required as perACTD is not available the DMF will be required.4.1.2 The DMF may be submitted via an electronic copy (CD) or a hardcopy(optional) directly to the NPCB to maintain confidentiality of thecontents.4.1.3 The NPCB may accept a CEP issued by European Directorate for theQuality of Medicine (EDQM) in lieu of the DMF of an API.4.2 REQUIRED INFORMATIONThe API information can be submitted to National Pharmaceutical ControlBureau (NPCB) in one of the following three options:• Option 1: Drug Master File (DMF) procedure; or• Option 2: Certificate of suitability of the European Pharmacopoeia(CEP); or• Option 3: Full details of “Part II S ACTD” in the Product DossierThe applicant should clearly indicate at the beginning of the API section (inthe Product Dossier) how the information on the API for each APImanufacturer is being submitted. The API information submitted by theapplicant/ FPP manufacturer should include the following for each of theoptions used.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 315
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PART III: NON-CLINICAL DATADrug Reg
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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