DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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