Abstract
The approval of medicines in different countries across the world has been and still is performed by regulatory agencies according to their national regulations, although attempts to harmonise the regulations have been made for several years within the GCC region. The harmonisation of the regulatory review processes in the GCC states was initiated following the issuance of the GCC Health Ministers’ Council Decree No. 8 in 1976 regarding the formation of a study group to report on how a centralised registration review system should be established to monitor the marketing of medicines and develop common guidelines for the participating authorities (Al-Essa 2011).
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Reference
Al-Essa, R. (2011). An evaluation of the regulatory review processes, the quality of decision-making and strategic planning in the Gulf Cooperation Council (GCC) states. Doctor of Philosophy thesis, The Welsh School of Pharmacy, Cardiff University.
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2015 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Al-Essa, R.K., Al-Rubaie, M., Walker, S., Salek, S. (2015). The Centralised Regulatory Review in the Gulf Region. In: Pharmaceutical Regulatory Environment. Adis, Cham. https://doi.org/10.1007/978-3-319-17590-4_7
Download citation
DOI: https://doi.org/10.1007/978-3-319-17590-4_7
Publisher Name: Adis, Cham
Print ISBN: 978-3-319-17589-8
Online ISBN: 978-3-319-17590-4
eBook Packages: MedicineMedicine (R0)