COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND BRAZIL
Journal Title: International Journal of Drug Regulatory Affairs - Year 2016, Vol 4, Issue 2
Abstract
This aims to compare the generic drug approval and registration process in the regulatory market of Europe, USA and Brazil. Based on the information collected from various sources such as regulatory sites, Government websites, discussion with regulatory agent, interviewing pharma professionals and literature survey from various journals, a clear picture on the generic drug approval and registration process of each country was drawn. The different authorities’ viz. European Medicines Evaluation Agency (EMEA) of Europe, Food Drug Administration (FDA) of USA and National Health Surveillance Agency (ANVISA) of Brazil carried out the generic drug approval and registration process in the respective countries. After analysing the various requirements for the generic drug approval in the above stated countries, it was concluded that the regulatory guidelines of Europe and Brazil was not well defined. But FDA gives very much well defined requirements.
Authors and Affiliations
Joseph Lincy, George Mathew, Malaviya Kalpesh K, Chacko Bincy K, Badjatya Jitendra Kumar
Keywords
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