Tagged with BIA

MEA For decades, the Middle East has faced a disproportionately high burden of rare genetic disorders, fuelled both by deep-rooted cultural practices and an overreliance on Western genomic data. Fast forward to 2026, and massive genome projects across the Gulf region are attempting to shift the narrative. Backed by immense sovereign…

LatAm From the perspective of international pharmaceuticals developers, Latin America can be considered a region of exceptional potential owing to solid market fundamentals and significant untapped opportunities. “I am convinced that we are poised to become among the most dynamic regions for growth momentum globally driven by multiple factors: among them…

LatAm When it comes to pharmaceutical exports, Latin America has historically been confined to the margins of the global life science industry. In 2023, the region accounted for a mere one percent of worldwide pharmaceutical exports, down from 1.97 percent a decade earlier, despite housing over eight percent of the world’s…

LatAm From cancer treatments to cardiovascular drugs, access to innovative medicines in South America lags behind developed market norms with patients forced to endure considerable delays for therapies that are already considered global standards. According to the Waiting to Access Innovative Therapies (W.A.I.T.) Indicator from FIFARMA, an association representing research-based pharma…

Global 2025 was a year of volatility for pharma and healthcare. In particular, the speed with which the administration of Donald Trump makes (and often then changes) consequential policy decisions has left industry stakeholders in the US and globally scrambling to fall in line. There are already clear winners and losers…

MEA Some of the top recent stories from pharma and healthcare in the Middle East and Africa, including Saudi Arabia’s pharma pitch to US investors, a new fund to bring forward Saudi biotechs, Egypt’s collaboration with Turkey on pharma manufacturing, and China’s ‘health silk road’ in Africa.   Saudi Arabia pitches…

LatAm Vaccination remains the most powerful public health intervention ever devised, preventing an estimated 4.4 million deaths each year, according to the WHO. Yet with misinformation spreading faster than science, and routine immunisation disrupted by pandemic aftershocks, even long-protected regions are witnessing a resurgence in preventable diseases. In Latin America, where…

Pharma Legal Handbook 1.Please make a general introduction to the public health sector in your country and its organization Saudi Arabia provides universal health coverage primarily funded by the government through a tax-based model. The healthcare system is organized in a tiered structure led by the Ministry of Health (MOH), which operates: •…

Pharma Legal Handbook Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? The Ministry of Health (MOH) is the primary body responsible for public health in Saudi Arabia. It sets national health policies, issues licenses to healthcare providers (public and private),…

Pharma Legal Handbook What are the pricing models, processes and principles for originator drugs? Originator drugs (innovator medicines) are priced by the Saudi Food and Drug Authority (SFDA) following the principles outlined in its 2023 Drug Pricing Guidelines. The pricing process includes: External Reference Pricing (ERP): SFDA compares prices with a reference basket…

Pharma Legal Handbook Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Yes. The SFDA published the Economic Evaluation Studies Guideline (PDF, July 10, 2024), which outlines comprehensive methods and includes a checklist. Followed by the Pharmacoeconomic Submission Portal Manual (January 2025), detailing dossier preparation and submission protocols.…

Pharma Legal Handbook In addition to the clinical data obtained through clinical studies please list the data required for   a. Market approval In addition to clinical trial data, the following documents are required for market authorization in Saudi Arabia: Quality/CMC Module: Includes full GMP certificates (PIC/S or WHO type) and a local…