Herbal Products Regulatory Issues In GCC, Opportunities And Obstacles | 106952
Journal of Traditional Medicine & Clinical Naturopathy
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The trend for herbal medicinal products has been increasing within GCC region specially after online
stores heavily promoted these products. The main marketing and sales sectors include sexual activity,
cosmetic and slimming products. While local sellers and distributors facing the problems with local
authorities for registration of the products and selling them under legal umbrella. The main issue is in
the medical claims of the products which in need for scientific and clinical trials evidences, secondly the
regulations of pharmaceutical firms such as tablets, capsules and syrup forms. These forms as per regulations
of Saudi food and drug authority that registration as herbal and health product with drug sector in need for
CTDs and licensing of the manufacturing site by SFDA, which worth a lot (up to 50,000$). For this reason,
manufacturers facing problems with registration of the products within Saudi market. In order to overstep
this, usually it has been asked for either simple product as tea form or powder form with maximum five
ingredients each without medical claims and just the claim of food (dietary) complement or drinking herb.
Till SFDA announces that there are new regulations would be by 2020, registration of these products will be
kept in this way.
Diaa Hussein has completed his MBBch from Faculty of Medicine, Ain Shams University, Cairo, Egypt. He joined Glaxosmith Klein, Egypt as Medical Representative and then joined SEDICO, Egypt as a Product Manager. Currently, he is a Regulatory Affairs Manager at Advanced International Pharmaceutical Company in Jeddah responsible for regulatory laws related to Saudi Food and Drug Authority.