(3.227.235.216)
Users online: 2290    [ij] [ij] [ij] 
Email id
 

Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 12
First page : ( 5653) Last page : ( 5668)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.01025.9

A Review on the Centralised Registration Procedure in the Gulf Cooperation Council (GCC) Region

Khan S. Umar, Kamaraj R.*

Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur-603203, Kanchipuram, Tamil Nadu, India

*Corresponding Author E-mail: monishakamaraj@gmail.com

Online published on 18 May, 2019.

Abstract

Regulatory Affairs (RA) is a profession which acts as the interface between drug regulatory authorities and regulated industries such as pharmaceuticals, medical devices, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also have a peculiar meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods). The Gulf Cooperation Council (GCC) region is treated as “emerging market” for pharmaceuticals when compared to another region. The objective of this study was to consider regulatory authorities of each states of GCC (Saudi Arabia, UAE, Bahrain, Kuwait, Oman, Qatar, Yemen) and pharmaceutical association perspective in the locality to evaluate review process, quality and effective measures used to improve the duration and approval process to determine the assets and liability of the centralized registration procedure.

Top

Keywords

Gulf Cooperation Council Drug Registration (GCC-DR), Gulf Cooperation Council Centralize procedure (GCC-CP), registration requirements, regulatory process, Pharmaceutical.

Top

  
║ Site map ║ Privacy Policy ║ Copyright ║ Terms & Conditions ║ Page Rank Tool
514,531,047 visitor(s) since 30th May, 2005.
All rights reserved. Site designed and maintained by DIVA ENTERPRISES PVT. LTD..
Note: Please use Internet Explorer (6.0 or above). Some functionalities may not work in other browsers.