A generic drug is more efficient, safe and low-cost alternative of the innovator or branded drug in the market. They are similar to the branded drugs in strength, quality, purity and their safety and efficacy have been proven since they have been in the market for a longer time. The availability of generic medicine should be made easier throughout the world. The US has one of the most demanding regulatory authorities and registration of drug products will be a long process if not complied with the US Food and Drug Administration (USFDA) guidelines. Abbreviated New Drug Application is the application to be filed for registering generic drug. One of the main tasks of the regulatory authorities is to ensure that the drug development, manufacture and testing has been carried out according to the regulations and guidelines and that everything is documented accordingly. International Conference on Harmonization (ICH) established a harmonized format for submission of application on registering drug products. This paper approaches the registration requirements of generic drugs in the form a dossier for market authorization in the US.

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Background: The Abbreviated New Drug Application commonly referred as ANDA is an application that contains data submitted to US FDA for the review and prospective marketing authorization of generic drugs. The conduct of the reviewing of the application is done by the Division of Filing Review (DFR), Office of Regulatory Operations (ORO) in the Office of Generic Drugs (OGD). The format of ANDA: USFDA recommends the submission of ANDA applications as per ICH Common Technical Document (CTD) format. Module 3: Module 3 of CTD contains Chemistry, Manufacturing and Control (CMC) information including all the supporting details verifying that was summarised in section 2.3 which is the quality overall summary. Evaluation of ANDA: For the evaluation of an Abbreviated New Drug Application in the US, its Office of Generic Drugs (OGD) has developed a Question-based Review (QbR) for its CMC section which is mainly focussed on the critical quality attributes. Conclusion: The implementation of Questionbased Review programme is yielding good improvements in FDA's division of Office of Generic Drugs (OGD), i.e., by advancing the review pattern of the ANDA CMC section without compromising quality and efficacy for the indication of the generic product.

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