Abstract

A BRIEF ANALYSIS OF REGULATORY STRUCTURE AND APPROVAL PROCESS OF PHARMACEUTICALS IN GCC

Konuri Dinesh Chandra*, A. Elphine Prabahar, Nadendla Rama Rao

ABSTRACT

Regulatory authorities in both developed and developing countries share the responsibility of ensuring the access of safe and effective medicines to patients; however their structures, strategies, and practices vary significant. The gulf cooperation council region is consider as “emerging market for pharmaceutical export and bilateral trade some incidents of year 2008-09 generics will comprise a significant part of the pharmaceutical sector in the GCC The aim of this study was to evaluate the Gulf Cooperation Council (GCC) regulatory systems (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates (UAE)) in order to develop a harmonized strategy. Seven GCC authorities to provide details of their review process and the quality measures used to improve their assessment procedures for applicability and practicality in the GCC region like recession or economic slowdown in highly well off and regulated market of EU and US raised the demand for alternate destinations for business. Smaller pharma markets such as Qatar and Bahrain are likely to experience higher growth than the comparatively developed market of Saudi Arabia. The GCC pharmaceutical sector has been growing steadily along with the general uptrend within the region.

Keywords: Gulf Cooperation Council, Pharmaceutical sector, Regulatory Requirements.