Pioneering Advantage in Generic Drug Competition

This aims to compare the generic drug approval and registration process in the regulatory market of Europe, USA andBrazil. 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, aclear picture on the generic drug approval and registration process of each country was drawn. The differentauthorities’ viz. European Medicines Evaluation Agency (EMEA) of Europe, Food Drug Administration (FDA) ofUSA and National Health Surveillance Agency (ANVISA) of Brazil carried out the generic drug approval andregistration process in the respective countries. After analysing the various requirements for the generic drug approvalin the above stated countries, it was concluded that the regulatory guidelines of Europe and Brazil was not welldefined. But FDA gives very much well defined requirements.

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MARKETING AUTHORIZATION OF GENERIC DRUG: GLOBAL ISSUE AND CHALLENGES

International Journal of Drug Regulatory Affairs ◽

10.22270/ijdra.v1i3.5 ◽

2013 ◽

Vol 1 (3) ◽

pp. 1-6

Author(s):

Pankaj Kashyap ◽

Eshant Duggal ◽

Parveen Budhwar ◽

Jitendra Kumar Badjatya

Keyword(s):

Generic Drug ◽

Patent Protection ◽

Drug Approval ◽

Approval Process ◽

Generic Medicines ◽

Healthcare Provision ◽

Pharmaceutical Markets ◽

Global Issue ◽

Drug Approval Process ◽

High Level

Generic medicines are those whose patent protection has expired, and which may be produced by manufacturers otherthan the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost savingmeasure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Theobjective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory andlegislative level, from originator medicines. It describes the current and historical regulation of medicines in theworld’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between genericsand their originator equivalents including the reasons for the cost differences seen between originator and genericmedicines. This article refers to the general generic drug approval process in India, USA, and Japan. They havedifferent regulation and approval process.

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