Regulatory Requirement for Pharmaceutical Marketing in USA, EU and GCC: A Comparison

Authors

  • Shetty A. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India
  • Dixit M. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India
  • Charyulu R.N. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India
  • Bengre P. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India
  • Rao M.S. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India
  • Thomas S. Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, Karnataka, India

DOI:

https://doi.org/10.37591/rrjodfdp.v1i3.318

Abstract

The Gulf Cooperation Council (GCC) pharmaceutical are known to be a semi-regulated market when compared with European Union (EU) and Unites States of America (USA) drug regulatory market. Product registration in GCC was challenging task in comparison to EU and USA due to lack of proper harmonised guidelines and diversity in registration procedure. The six GCC member states namely Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates have established a good regulatory guideline of their own, for drug marketing. Need for establishment of well-regulated guidelines is to ensure quality, safety and efficacy of drugs. The regulatory guidelines of EU and USA are standard for other regulatory agencies worldwide, and also to semi-regulated countries of GCC. This paper mainly focuses the various aspects of registration procedures, scope and time lines for the registration in USA, EU and GCC. A comparison between regulatory procedures of GCC with USA and EU countries will give us complete view on GCC countries being well regulated and emerging pharmaceutical market.

 

Keywords: United States Food and Drug Administration (USFDA), Gulf Cooperation Council (GCC), European Medicines Agency (EMA)

 

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Published

2019-02-26

Issue

Vol. 1 No. 3 (2014)

Section

Review Article

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