MARKETING AUTHORIZATION OF GENERIC DRUG: GLOBAL ISSUE AND CHALLENGES
Journal Title: International Journal of Drug Regulatory Affairs - Year 2013, Vol 1, Issue 3
Abstract
Generic medicines are those whose patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. The objective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory and legislative level, from originator medicines. It describes the current and historical regulation of medicines in the world’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between generics and their originator equivalents including the reasons for the cost differences seen between originator and generic medicines. This article refers to the general generic drug approval process in India, USA, and Japan. They have different regulation and approval process.
Authors and Affiliations
Kashyap Pankaj, Duggal Eshant, Budhwar Parveen, Badjatya Jitendra Kumar
Keywords
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