Pharmaceutical Regulatory Environment Challenges and Opportunities in the Gulf Region /

• Main Authors: Al-Essa, Reem K. (Author), Al-Rubaie, Mohammed (Author), Walker, Stuart (Author), Salek, Sam (Author)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Adis, 2015.
• Subjects: Medicine.; Public health.; Pharmacotherapy.; Medicine & Public Health.; Public Health.

The Middle East represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is con...

Table of 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.