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A Comparative Study on the Dossier Submission for Pharmaceutical Products: Global Review

Author

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  • Swathi J

    (Department of Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty – 643001, The Nilgiris, Tamil Nadu, India)

  • Muthu Pranesh K

    (Department of Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty – 643001, The Nilgiris, Tamil Nadu, India)

  • Pavithran T

    (Department of Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty – 643001, The Nilgiris, Tamil Nadu, India)

  • Nivetha D

    (Department of Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty – 643001, The Nilgiris, Tamil Nadu, India)

  • D Nagasamy Venkatesh

    (Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty – 643 001, The Nilgiris, Tamil Nadu, India)

  • N Arun

    (Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty – 643 001, The Nilgiris, Tamil Nadu, India)

  • SD Shanmugakumar

    (Jyothishmathi Institute of Pharmaceutical Sciences, Karim Nagar -505 001, Telangana, India)

Abstract

The Dossier is a series of papers on various topics. The process of reviewing and analyzing the pharmaceutical product dossier, which has administrative, quality, non-clinical and clinical data. The Drug Regulatory Authority in a specific country regulates and authorizes this process and the process is known as New Drug Application in the United States of America, Marketing Authorization Application in the European Union and other countries simply as the Registration Dossier. For dossier preparation.

Suggested Citation

  • Swathi J & Muthu Pranesh K & Pavithran T & Nivetha D & D Nagasamy Venkatesh & N Arun & SD Shanmugakumar, 2023. "A Comparative Study on the Dossier Submission for Pharmaceutical Products: Global Review," Biomedical Journal of Scientific & Technical Research, Biomedical Research Network+, LLC, vol. 48(1), pages 39059-39063, January.
    • Handle: RePEc:abf:journl:v:48:y:2023:i:1:p:39059-39063
    DOI: 10.26717/BJSTR.2023.48.007589
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    JEL classification:

    • R00 - Urban, Rural, Regional, Real Estate, and Transportation Economics - - General - - - General
    • Z0 - Other Special Topics - - General

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