Abstract
AN OVERVIEW ON GENERIC DRUG APPROVAL PROCESS IN US AND EUROPE

*Abdul Mannan, Nahl Imtiaz Mohammed, Rahila Fatima, Shafiya Begum and Faroza Khatoon

ABSTRACT

Generic drugs are identical to branded drugs in terms of dosage form, safety, strength, route of administration, performance, and intended use. Developing a new drug requires a great amount of research work in chemical, manufacturing, control, pre-clinical, and clinical process. Every country has its own regulatory authority which is responsible to enforce rules & regulations and issue guidelines to regulate the marketing of drugs. For a generic drug to be marketed the company must submit Abbreviated New Drug Applications Approval. This article focuses on the drug approval process in different countries like US, and Europe. Drug approval Standards in US is considered most demanding and truly reliable in the world whereas the approval process of Europe is typical and contains more data to be summarized for dossier submissions.

Keywords: ANDA, Federal regulations, Hatch Waxman act, eCTD, EMA, Marketing authorization.


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