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Pharmaceutical Regulatory Environment

Challenges and Opportunities in the Gulf Region

  • Reem K. Al-Essa
  • Mohammed Al-Rubaie
  • Stuart Walker
  • Sam Salek

Table of contents

  1. Front Matter
    Pages i-xiii
  2. Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
    Pages 1-27
  3. Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
    Pages 29-64
  4. Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
    Pages 65-78
  5. Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
    Pages 79-101
  6. Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
    Pages 103-114
  7. Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
    Pages 115-140
  8. Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
    Pages 141-154
  9. Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
    Pages 155-170
  10. Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
    Pages 171-188
  11. Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
    Pages 189-203
  12. Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
    Pages 205-229
  13. Reem K. Al-Essa, Mohammed Al-Rubaie, Stuart Walker, Sam Salek
    Pages 231-236

About this book

Introduction

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 considered critical to the future regulatory environment in this region.

This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which,  if fully implemented, could have a significant impact on patients’ access to new medicines.

Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.

Keywords

Harmonized centralized review procedure Market approval for new drugs National metrics Regulatory review practices Seven Gulf Cooperation Council states

Authors and affiliations

  • Reem K. Al-Essa
    • 1
  • Mohammed Al-Rubaie
    • 2
  • Stuart Walker
    • 3
  • Sam Salek
    • 4
  1. 1.Regulatory Affairs Consultant Executive Directive, Kuwait Advancement for Conference and Exhibition Management Est.Kuwait CityKuwait
  2. 2.Ministry of HealthDirectorate General of Pharmaceutical Affairs and Drug ControlMuscatOman
  3. 3.Founder of Centre for Innovation in Regulatory ScienceLondonUnited Kingdom
  4. 4.University of HertfordshireDepartment of Pharmacy, School of Life and Medical SciencesHatfieldUnited Kingdom

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-319-17590-4
  • Copyright Information Springer International Publishing Switzerland 2015
  • Publisher Name Adis, Cham
  • eBook Packages Medicine
  • Print ISBN 978-3-319-17589-8
  • Online ISBN 978-3-319-17590-4
  • Buy this book on publisher's site
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