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Regulatory Requirements and Registration Procedure for Generic Drugs in USA

1, 1, 1

  1. 1Department of Regulatory affairs, NITTE (Deemed to be university), NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte, Mangalore, Karnataka, INDIA.

CORRESPONDENCE

Sandeep DS

Department of Regulatory affairs, NITTE (Deemed to be university), NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte, Mangalore, Karnataka, INDIA.

sandypharama@gmail.com

Received: 02-03-2018; Accepted: 17-05-2018.

Volume 52, Issue 4 · pp. 544-549 · 2018 · DOI: 10.5530/ijper.52.4.63

ABSTRACT

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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    Rafi, N., DS, S., & V, A. N. (2018). Regulatory Requirements and Registration Procedure for Generic Drugs in USA. Indian Journal of Pharmaceutical Education and Research, 52(4), 544-549. https://doi.org/10.5530/ijper.52.4.63

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    © 2018 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. CC BY 4.0