Regulatory hurdles affecting US companies to register and market dietary supplements in the Middle East Region and what US dietary supplement manufacturers need to understand

5^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs

August 03-05, 2015 Orlando, USA

Reshma Castelino

Vitane Pharmaceuticals, UAE

Posters-Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

The GCC (Gulf cooperation Council) pharma market (inclusive of Dietary supplements) market is dominated by Saudi Arabia, which accounts for two thirds of the total GCC region in value terms. Along with UAE and Kuwait, these three states account for 91% of GCC dietary supplement sales. These countries however have very stringent regulatory guidelines for both Dietary supplements and Pharmaceutical products. US Dietary supplement companies face significantcomplexities understanding the guidelines followed in this region. My presentation would be a step by step approach explaining the guidelines, the market size, and the nature of products that qualify as Dietary Supplements in these countries. The objective would be to help companies:- a) Dossiers - Understand how they need to prepare Dossiers of Dietary supplements. b) Labelling - I will explain compliance with local laws and, c) Process - That needs to be followed from product shortlisting to marketing.

Biography :

Email: reshma@vitanepharma.com