Pharmaceutical Regulatory Environment
Challenges and Opportunities in the Gulf Region
Buch in deiner Nähe kaufen
Beschreibung
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.
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.
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
Autor*in
Reem K. Al-Essa
Themen in »Pharmaceutical Regulatory Environment«
Harmonized centralized review procedure Market approval for new drugs National metrics Regulatory review practices Seven Gulf Cooperation Council states pharmacotherapy