DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)Applicant shall make payment within thirty (30) days from the date of approval for payment.The application form shall be deleted from the system if payment has not been made withinthe specified timeframe.8.3.2 NON-SATISFACTORYIf the application is found incomplete during the screening process, the application shall berejected and the applicant shall be notified via the system.Note:If there is any decision made by the applicant/ required by the Authority in certain casesto withdraw a submitted application for registration of a product, at any stage ofevaluation prior to its approval, the applicant shall notify the Authority and shall state thereasons for the decision.8.4 EVALUATION OF APPLICATION8.4.1 INITIATION OF REVIEWUpon confirmation of payment, the application with the submitted data shall be evaluated.Review of applications shall follow a queue system. There shall be separate queues for thedifferent categories of products and/or according to level of claims i.e. general, medium orhigh claim.Priority review may be granted for product which is intended for treatment of a serious orlife-threatening disease, where the likelihood of death is high unless the course of thedisease is interrupted.8.4.2 CORRESPONDENCECorrespondence via the system shall be sent to the applicant if there is any clarification andfurther supplementary data/ information, documentation or samples pertaining to theapplication, if deemed necessary by the Authority.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 79