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  • Reg Flowchart HumanPharma

    Uploaded by

    Sughra Chandio
    6 views1 page
    This document outlines the process for obtaining a Grant of Drug Registration for a pharmaceutical drug intended for human use from the Drug Regulatory Authority of Pakistan (DRAP). The process involves submitting an application dossier and fee challan, technical evaluation, inspection if required, review at a Registration Board meeting, and potentially an appeal process, with the goal of receiving a registration letter if approved.

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    Reg_flowchart_HumanPharma

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    This document outlines the process for obtaining a Grant of Drug Registration for a pharmaceutical drug intended for human use from the Drug Regulatory Authority of Pakistan (DRAP). The process involves submitting an application dossier and fee challan, technical evaluation, inspection if required, review at a Registration Board meeting, and potentially an appeal process, with the goal of receiving a registration letter if approved.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    6 views1 page

    Reg Flowchart HumanPharma

    Uploaded by

    Sughra Chandio
    This document outlines the process for obtaining a Grant of Drug Registration for a pharmaceutical drug intended for human use from the Drug Regulatory Authority of Pakistan (DRAP). The process involves submitting an application dossier and fee challan, technical evaluation, inspection if required, review at a Registration Board meeting, and potentially an appeal process, with the goal of receiving a registration letter if approved.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
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    of 1

    Grant of Drug Registration (Pharmaceutical drug for human use)

    (For complete Process Description, Checklist and relevant Forms Click Here)

    Manufacturer / Applicant DRAP

    Shortcoming letter issued

    Fill Drug (Pharmaceutical)


    Registration Application Non-
    Form 5F Receive Application Dossier Compliant

    Submit Fee Challan


    Technical Evaluation and Verification by
    Pharmaceutical Evaluation Cell

    Submit Compliant
    Application
    Dossier

    New Drug/Subsequent Generic


    (product Specific Inspection if Generic Drugs
    required)

    Registration
    Not approved Deferred
    Board Meeting

    Receive Rejection Expert opinion (if


    Rejection letter required)
    letter

    Approved

    Firm submits application within 60


    days against decision of DRB to the
    Appellate Board. Locally Manufactured Imported Drugs

    Not Dosage form specific


    Recommended inspection (if required)

    Recommended

    Issue Registration Letter (Subject


    Receive Registration
    to price fixation by Federal
    Letter
    Government)

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