Pharmaceutical Regulatory Environment
Sam Salek, Mohammed Al-Rubaie, Stuart Walker, et al.
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Springer International Publishing
Naturwissenschaften, Medizin, Informatik, Technik / Allgemeines
Beschreibung
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.
Kundenbewertungen
Harmonized centralized review procedure, Seven Gulf Cooperation Council states, pharmacotherapy, National metrics, Regulatory review practices, Market approval for new drugs