publication . Article . Other literature type . 2017

GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

Pankaj Kumar*, Bharti Mangla2;
Open Access English
  • Published: 04 Dec 2017
Abstract
Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by original innovator drug manufacturer and adds only bioequivalence studies. Therefore it is very difficult and challenging task to approve a drug by the manufacturing companies,...
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doi: 10.5281/zenodo.1079864 , 10.5281/zenodo.1079863
Subjects
free text keywords: Generic drug, Regulatory authority, Drug development, FDA, ANDA, ICH
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ZENODO
Article . 2017
Provider: ZENODO
Zenodo
Other literature type . 2017
Provider: Datacite
Zenodo
Other literature type . 2017
Provider: Datacite
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