BookReem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek.
Contents:
1. Overview of Medicines Regulatory Systems in the Gulf Region
2. The Regulatory Review Process in the Gulf Region
3. Regulatory Review Times in the Gulf Region
4. Quality Measures in the Gulf Regulatory Practices
5. The Current Status of the Common Technical Document
6. The Current Status of Drug Safety and Pharmacovigilance
7. The Centralized Regulatory Review in the Gulf Region
8. The Gulf States Assessment and Experience With the Centralised Procedure
9. The Pharmaceutical Companies Assessment and Experience With the Centralised Procedure
10. Proposal For an Improved Centralized Regulatory System
11. The Strategic Planning Process of the GCC Regulatory Authorities: Barriers And Solutions
12. The Regulatory Dilemma in the Gulf Region: The Way Forward.