• 21 July 2017

    CRITICAL AND COMPARATIVE ANALYSIS OF ANDA FILLING OF TABLETS IN INDIA, EUROPE AND US

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    ABOUT AUTHORS
    Ms. NEETU*, Dr. ANUPAMA SETIA, Mr. MUNISH THAKUR
    *JCDM COLLEGE OF PHARMACY,
    SIRSA-HARYANA (INDIA)
    *neetu.kaushal11@gmail.com

    ABSTRACT
    Abbreviated New Drug Application (ANDA) is an application used for regulatory submission for the authorization of generics drugs and its entry into a brand drug market. Generic drugs are pharmaceutical equivalent to the brand name drugs and distributed without patent protection. Different countries have different requirements for the registration of generic drugs and its own regulatory authority, which are responsible to enforce the rules and regulations, issue the guidelines to regulate the marketing of drugs. Various government agencies in regulating drugs are CDSCO- India, EDQM-Europe, and USFDA-US. Aim of title was to review the generic drug filing and different aspect of obtaining regulatory approval in order to get the marketing authorization in India, Europe & US. Involvement of regulatory in the generic drug development expedites the approval process and they review the queries carefully raised by the regulatory authorities and minimize them. To harmonize the different requirements, CTD format is used for filing the ANDA in respective countries. In this an attempt was made to highlight the difference between the registration requirements for generics drugs in India, Europe & US. The comparison parameters in the generic drug approval among different regions, which gives clear illustration where India lies in its generic drug approval process.

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