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Published on:June 2018
Indian Journal of Pharmaceutical Education and Research, 2018; 52(4):544-549
Review Article | doi:10.5530/ijper.52.4.63

Regulatory Requirements and Registration Procedure for Generic Drugs in USA


Authors and affiliation (s):

Naziya Rafi, Sandeep DS*, Anoop Narayanan V

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

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.

Key words: Generic drugs, Common technical document, ANDA, USFDA.

 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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