Dipen Gaykar
,
Dipen Gaykar
REVIEW ON REGULATORY PROCESS AND APPROVAL PROCESS OF PHARMACEUTICALS IN GCC COUNTRIES
Regulatory affairs is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world which ensures the access of safe and effective medicines to the patients. The gulf cooperation council region is considered as “Emerging market” for pharmaceuticals. The GCC healthcare market is projected to grow at 12.1% compound annual growth rate (CAGR) from an estimated US$ 40.3 billion to US$ 71.3 billion in 2020. The aim of the study was to develop a harmonized, regulatory review processes and timelines in the region with registration procedure of Kingdom of the Saudi Arabia and United Arab Emirates