Pharmaceutical Regulatory Environment

Challenges and Opportunities in the Gulf Region

Authors: Al-Essa, R.K., Al-Rubaie, M., Walker, S., Salek, S.

  • Examines the regulatory review practices in the seven Gulf Cooperation Council states, namely Kuwait, Iraq, Bahrain, Oman, Qatar, Saudi Arabia and the United Arab Emirates
  • Compares national metrics with those of the harmonised centralised review procedure, for companies wishing to gain market approval for new drugs in the region
  • Describes the current strategies and future opportunities for an improved regulatory environment in the Gulf region
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eBook 51,16 €
price for Spain (gross)
  • ISBN 978-3-319-17590-4
  • Digitally watermarked, DRM-free
  • Included format: EPUB, PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover 62,39 €
price for Spain (gross)
  • ISBN 978-3-319-17589-8
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
  • The final prices may differ from the prices shown due to specifics of VAT rules
Softcover 62,39 €
price for Spain (gross)
  • ISBN 978-3-319-36010-2
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
  • The final prices may differ from the prices shown due to specifics of VAT rules
About this book

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.

The Persian Gulf 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.

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

About the authors

Reem Al-Essa BPharm MSc PhD was the Drug Registration and Release Superintendent for six years of her 12 years experience with Ministry of Health, Kuwait. During this period she completed her MBA with distinction. She later undertook the EU2P MSc in Pharmacovigilance and Pharmacoepidemiology. Dr Al-Essa has published six journal articles and abstracts related to pharmaceutical regulation in the Gulf region.

Mohammed Hamdan Al-Rubaie BPharm MSc PhD is the Director of Drug Control, Directorate General of Pharmaceutical affairs and Drug Control, Oman Ministry of Health.He is a member of the GCC Central Registration Committee, and actively involved in many other GCC committees and working groups for the drafting of the GCC pharmaceutical regulations and policies. Dr Al-Rubaie was instrumental in forming the Pharmaceutical society in Oman and chaired it from 2010-2011.

Stuart Walker BSc, PhD, MFPM FRSC FIBiol, FRCPath, is the Founder of the Centre for Medicines Research International, the Centre for Innovation in Regulatory Science and Professor of Pharmaceutical Medicine, University of Wales, Cardiff. During his research career in academia & industry, he has supervised many PhD programmes in clinical development, regulatory policies, the benefit/risk assessment of medicines and health technology assessment, co-authored 280 research papers and edited 25 books. He is frequently involved in the organisation of international meetings on key issues that concern the regulatory review of medicines and has lectured extensively throughout Europe, the USA, the Asia-Pacific Region, Latin America and the Middle East.

Sam Salek PhD RPh FFPM MRPSGB MCMS FESCP is Professor of Pharmacoepidemiology at the University of Hertfordshire, Hatfield, visiting Professor at the Estate of Hessen, Germany, and Director of the Institute for Medicines Development, Cardiff, UK. Professor Salek’s research focuses mainly on four areas: development and application of patient-reported outcome measures; drug safety evaluation and pharmacovigilance; pharmacoeconomics and economic evaluation of healthcare; and pharmaceutical regulation & medicines development in the mature and emerging markets. He has published 19 books and 600 journal articles and abstracts. Professor Salek is a member of five Editorial Boards and an active member of several societies.

Table of contents (12 chapters)

  • Overview of Medicines Regulatory Systems in the Gulf Region

    Al-Essa, Reem K. (et al.)

    Pages 1-27

    Preview Buy Chapter 30,19 €
  • The Regulatory Review Process in the Gulf Region

    Al-Essa, Reem K. (et al.)

    Pages 29-64

    Preview Buy Chapter 30,19 €
  • Regulatory Review Times in the Gulf Region

    Al-Essa, Reem K. (et al.)

    Pages 65-78

    Preview Buy Chapter 30,19 €
  • Quality Measures in the Gulf Regulatory Practices

    Al-Essa, Reem K. (et al.)

    Pages 79-101

    Preview Buy Chapter 30,19 €
  • The Current Status of the Common Technical Document

    Al-Essa, Reem K. (et al.)

    Pages 103-114

    Preview Buy Chapter 30,19 €

Buy this book

eBook 51,16 €
price for Spain (gross)
  • ISBN 978-3-319-17590-4
  • Digitally watermarked, DRM-free
  • Included format: EPUB, PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover 62,39 €
price for Spain (gross)
  • ISBN 978-3-319-17589-8
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
  • The final prices may differ from the prices shown due to specifics of VAT rules
Softcover 62,39 €
price for Spain (gross)
  • ISBN 978-3-319-36010-2
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
  • The final prices may differ from the prices shown due to specifics of VAT rules
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Bibliographic Information

Bibliographic Information
Book Title
Pharmaceutical Regulatory Environment
Book Subtitle
Challenges and Opportunities in the Gulf Region
Authors
Copyright
2015
Publisher
ADIS
Copyright Holder
Springer International Publishing Switzerland
eBook ISBN
978-3-319-17590-4
DOI
10.1007/978-3-319-17590-4
Hardcover ISBN
978-3-319-17589-8
Softcover ISBN
978-3-319-36010-2
Edition Number
1
Number of Pages
XIII, 236
Number of Illustrations and Tables
79 illustrations in colour
Topics