Gulf Pharmaceutical Industries, UAE
Posters-Accepted Abstracts: Pharmaceut Reg Affairs
Kingdom of Saudi Arabia (KSA) is considered one of the most matured markets of the six Gulf Cooperation Council (GCC) member states with generic drug penetration, and as healthcare expenditure as a percentage of GDP is increasing (expected to be 5.16% by 2015), there is an opportunity for the generic market to grow. There are currently 24 manufacturers in KSA, with 11 more under registration. Some local trends discussed were the strategic partnerships local manufacturers have with multinationals, the increased capacity and expansion at local manufacturing as well as increased Contract Manufacturing (CMO) being done for foreign companies. While local KSA manufacturers do enjoy a majority generic drug market share, foreign drug companies are also entering KSA. There is a focus on increased share of distribution, increase in strategic alliances with local manufacturers, as well as an increase in the number of clinical trials being conducted in KSA for branded drugs. In general, the Saudi FDA (SFDA) regulations governing are very similar to FDA regulations, which guarantee the need for worldwide harmonization. Exceptions adopted to meet the specific needs for Saudi Arabia and GCC countries are of course considered. ├ó┬?┬?How to market generics and bio-similar in Saudi Arabia├ó┬?┬Ł gives comprehensive aspects such as legal framework, provisions affecting generic/bio-similar development and commercialization, reference medicinal product/generic listing or catalogue, requirements for registration & registration/evaluation process, format and content of the application, labelling/product monographs, fees, pharmacovigilance/post marketing surveillance, pricing and reimbursement, prescription and supply, and advertisement/promotion.
Pharmaceutical Regulatory Affairs: Open Access received 471 citations as per Google Scholar report