DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)8.1.3 REQUIREMENTS FOR PRODUCT REGISTRATIONApplicant shall submit the following requirements to support an application for productregistration, applicable according to different category of product:a) General requirements (either for full or abridged evaluation);i) Full Evaluation;(In accordance to ASEAN ACTD/ ACTR or ICH guidelines)OR• Part I - Administrative data and product information;• Part II - Data to support product quality (Quality Document);• Part III - Data to support product safety (Nonclinical Document); and• Part IV - Data to support product safety and efficacy (Clinical Document).ii) Abridged Evaluation.For details, please refer Appendix 2: Requirements for Product Registrationb) Specific requirements according to category of product (biologics, health supplementsand natural products).- Biologics : Refer Appendix 3: Guideline on Registration of Biologics- Healthsupplements- Naturalproducts: Refer Appendix 4: Guideline on Registration of HealthSupplements: Refer Appendix 5: Guideline on Registration of NaturalProductsFor regulatory control of active pharmaceutical ingredient (API), it is applicable to allpharmaceutical products either locally manufactured or imported, excluding biologics,health supplements and natural products.The implementation has begun with voluntary submission for New Drug Product (NDP) inApril 2011 and followed by;Phase 1 - New Drug Products (NDP) (mandatory in Jan 2012)Phase 2 - Generics (Scheduled Poison) (to be determined)Phase 3 - Generics (Non-scheduled Poison) (to be determined)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 74
Drug Registration Guidance Document (DRGD)No separate application for registration of the API is required. However, the requiredtechnical documentation pertaining to each API at Part 2.S ACTD (Part II Quality: DrugSubstance) shall be submitted as part of the application for product registration.For details pertaining to regulatory control of API, please refer Appendix 6: Guideline onRegulatory Control of Active Pharmaceutical Ingredients (API).8.1.4 CONDITIONS APPLIED ON PRODUCT REGISTRATIONApplicant shall comply with the following conditions applied on product registration. Failureto do so shall results in rejection of the application by the Authority.a) Applicant shall comply with all requirements as specified in the following appendicesand directions from the Authority:i) Appendix 7:Special Conditions for Registration for a Particular Product or Group of Products;ii) Appendix 8:List of Permitted, Prohibited and Restricted Substances;iii) Appendix 9:Labelling Requirements;iv) Appendix 10:Guideline on Patient Dispensing Pack for Pharmaceutical Products in Malaysia(Applicable to pharmaceutical products only).b) Applicant shall provide supplementary data/ information, documentation or samples, ifrequested by the Authority;c) Applicant shall respond and provide feedback for the requested supplementary data/information, documentation or samples by the Authority within the specified timeframe.If the applicant is unable to submit the requirements within the specified timeframe, awritten request for an extension shall be submitted to NPCB;d) Application shall be rejected if the applicant fails to submit required supplementary data/information, documentation or samples within six (6) months from the firstcorrespondence date;(Reference: Circular Bil (08) dlm. BPFK/PPP/01/03)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 75
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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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