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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…

Pharma Legal Handbook Are there any Managed entry agreements in place in your country? (If so, please list them) Yes, Saudi Arabia has implemented two types of Managed Entry Agreements (MEAs) under the Ministry of Health’s “Managed-Entry Agreement Policy” issued in January 2021. These include: A. Finance-based Price/Volume Agreement 1. Fundamentals & rationale…

Pharma Legal Handbook Which are the main actors involved in public procurement and tendering? In Saudi Arabia, the main actors in the public procurement and tendering process for pharmaceuticals include: NUPCO (National Unified Procurement Company): Acts as the central purchasing agent for the Ministry of Health (MOH), Ministry of Defense, National Guard, and…

Pharma Legal Handbook Please describe the main cost containment policies in place in your country and their fundamental principles   a. Pricing and impact of generic/biosimilar approval The SFDA applies automatic price reductions for generics and biosimilars: The 1st generic is priced ≥35% lower than the originator. The 2nd generic is ≥55% lower.…

France As CEO of Transgene, Alessandro Riva is steering the French biotech into a new era of cancer immunotherapy. Building on more than four decades of scientific excellence, Transgene is advancing a pioneering platform of individualised neoantigen therapeutic vaccines (INTVs) designed to re-educate the immune system to target solid tumours. With…

France Under Laurence Rodriguez’s leadership, GenSight Biologics is charting a bold path forward after a period of reset, advancing groundbreaking gene therapies for rare ophthalmic and mitochondrial diseases. She reflects on rebuilding the organisation, preparing a pivotal Phase III study for the gene therapy GS010/LUMEVOQ, and shaping the future of optogenetic…

LatAm Adium is one of Latin America’s most expansive pharmaceutical groups, operating across 18 countries with a workforce of 7,000 employees. The organisation has unified its brand identity across the region whilst establishing world-class infrastructure and capabilities spanning oncology, rare diseases, and speciality therapeutics. The company´s strategic vision centres on positioning…

France Born from a serendipitous scientific discovery in Montpellier, Abivax has evolved into one of France’s most promising global biotechs. Led by CEO Marc de Garidel, the company is harnessing its pioneering miR-124-based therapy, obefazimod, to redefine treatment possibilities in inflammatory bowel disease through an entirely new, immune-balancing mechanism of action.…

France Genopole stands as one of France’s leading bioclusters, seamlessly integrating world-class research, entrepreneurship, and industrial engagement to support over 80 companies across health and the bioeconomy. Under Gilles Trystram’s leadership, the cluster nurtures innovation from start-up creation to scaling, leveraging strategic partnerships with institutions like Université Paris-Saclay and specialised platforms…

Brazil Sylvester Feddes, Country President of Novartis Brazil, outlines the country’s rise as a top global market driven by strong public-private healthcare infrastructure and vast unmet needs. With nearly 100 active clinical trials and major launches ahead across cardiovascular-renal-metabolic, immunology, neurology and oncology, Novartis is pairing scientific innovation with new access…

Colombia Francisco Rossi, Director of Colombia’s National Food and Drug Surveillance Institute (INVIMA), discusses the agency’s ongoing transformation to become a faster, more transparent, and globally recognised regulator. Since his return in 2024, Rossi has prioritised reducing backlogs, launching the digital platform InvimÁgil, and refocusing INVIMA on public health surveillance. He…

Taiwan Carl Wegner, President of AmCham Taiwan, reflects on his first months in the role, highlighting the chamber’s advocacy mission, the strength of its committees, growing US–Taiwan engagement, and major opportunities in healthcare, public-private partnerships, and innovation, especially around the Healthy Taiwan initiative.   Taiwan is the seventh largest US trading…