Pharma Legal Handbook 1.Price Control How does price control at ex-factory prices work in your country? Ex-factory prices are strictly regulated by the Saudi Food and Drug Authority (SFDA) using External Reference Pricing (ERP). SFDA sets a Ceiling CIP price based on the lowest value from a basket of 34 reference countries. Manufacturers…
MEA The Middle East and Africa (MEA) pharmaceutical market is booming. According to IQVIA, the market reached USD 32.6 billion in value last year with value sales growth at 10.5 percent versus the previous year. Saudi Arabia, the largest market in MEA at USD 11.6 billion in value, expanded at 9.1…
MEA A selection of top stories coming out of the Middle East and Africa’s pharma sector: Egypt’s Gypto Pharma partners with US drugmaker Dawa to expand the local production of medicines; Jordan’s Hikma makes a USD 1 billion investment pledge for US manufacturing and R&D, and Riyadh-headquartered private equity firm Jadwa…
Saudi Arabia Localising the production of medicines has become a core priority for the Saudi government over the past decade as it attempts to increase national health security, create highly skilled jobs, and grow the non-oil economy. Multinational innovators now have a wide range of incentives (as well as enforcement tactics) to…
Saudi Arabia With Saudi Arabia striving to position itself as a regional leader in biopharmaceutical R&D by 2030 and to cement itself as a global hub before 2040, there has been a coordinated attempt to align research centres across the country under a unified national framework. This National Biotech Strategy, unveiled by…
Saudi Arabia Saudi Arabia has long represented an alluring marketplace for the global MedTech industry. Not only does the Kingdom constitute the largest spender on healthcare across the Middle East and North Africa region, but its medical device sector has been experiencing consistent compound annual growth rates of over six percent and…
Saudi Arabia Eye health is vital to everyday life, yet it remains heavily underfunded compared to fields like cancer or diabetes. While global spending on oncology is set to reach USD 440 billion by 2028, ophthalmology will receive just USD 38 billion, according to IQVIA. This gap is striking given the growing…
Saudi Arabia With increased average disposable income in Saudi Arabia eliciting more sedentary lifestyles and less healthy dietary choices, more than 68 percent of all mortality in the Kingdom is nowadays attributed to non-communicable diseases (NCDs). Not only does this come at immense cost to the public purse, but also presents a…
Saudi Arabia When it was first initiated back in 2016, in the wake of the launch of Vision 2030, few industry insiders could have anticipated just quite how radical Saudi Arabia’s Health Sector Transformation Program (HSTP) would turn out to be. Since then, several significant milestones have been reached – the retreat…
Saudi Arabia Saudi Arabia’s pharmaceuticals market grew an impressive 9.1 percent in 2024 underscoring its position as the regional heavyweight, and projecting a sales value of around USD 11.6 billion, which constitutes approximately 32 percent of the total share of the Middle East and Africa (MENA) region in the global marketplace. Yet…
Saudi Arabia Amidst the hype of Saudi Arabia’s embrace of innovative therapies and technologies, the concepts of access and affordability can often be forgotten. However, the Saudi government remains the dominant healthcare payer in the country and, with medicines already consuming over 20 percent of national healthcare spending, is putting increasing emphasis…
Saudi Arabia Saudi Arabia’s pharmaceutical sector continues its impressive growth leadership within the region. With a 9.1 percent market growth in 2024 and a projected USD 11.6 billion in sales, the Kingdom now commands nearly a third of the entire MENA pharma market. But this story goes far beyond impressive numbers. Through…
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