DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)Application shall be rejected if the applicant fails to respond to the correspondence fromNPCB to submit the required supplementary data/ information, documentation or sampleswithin six (6) months from the first correspondence date. (Reference: Circular Bil (08) dlm.BPFK/PPP/01/03)8.4.3 STOP CLOCKUnder review.8.4.4 TIMELINE FOR PRODUCT REGISTRATIONTable VII:No.(A)Full EvaluationProduct Category* Duration(Inclusive screening process)1. New Drug Products 245 working days2. Biologics 245 working days3. Generics (Scheduled Poison) 210 working days4. Generics (Non-Scheduled Poison) 210 working days(B)Abridged Evaluation*Duration(Inclusive screening process)5.Generics (Non-Scheduled Poison)(Product categories as stated in Table V above)80 working days6.Natural Productsa) Single active ingredientb) Two (2) or more active ingredientsa) 116 working daysb) 136 working daysNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 80
Drug Registration Guidance Document (DRGD)(B)Abridged Evaluation*Duration(Inclusive screening process)7. Health Supplementsa) ** Single active ingredientb) ** Two (2) or more active ingredientsa) 116 working daysb) 136 working days** Applicable for:i) General or Nutritional Claims; andii) Functional Claims (Medium Claims)c) Disease Risk Reduction Claims(High Claims)c) 245 working days* Upon receipt of complete application.8.5 REGULATORY OUTCOME8.5.1 DECISIONS OF THE AUTHORITYA regulatory decision shall be made based on the outcome of the evaluation of thesubmitted documentation, and samples (if applicable). An application may beapproved or rejected by the Authority, and the Authority decision will be sent viaemail/ official letter to the product registration holder.As stipulated under the CDCR 1984, Regulation 11(1), the Authority may, at anytime reject, as well as cancel or suspend the registration of any product if there aredeficiencies in safety, quality or efficacy of the product or failure to comply withconditions of registration.8.5.2 PRODUCT REGISTRATION NUMBERAs stipulated in Regulation 8(8), CDCR 1984, upon registration of a product by theAuthority, the product registration holder shall be notified by the Authority and aNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 81
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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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