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 Sandra Ramirez, Latam Area Lead, Astellas Pharma, outlines the company’s strong momentum across Mexico, Colombia, Argentina, and Chile, highlighting regulatory innovation, strategic partnerships, and expanded patient access. She discusses the strategic importance of Mexico’s new Global Capability Centre, the region’s growing role in clinical research, and how diversity, integrity, and…
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 From Hungary to Poland and now France, Nienke Feenstra has navigated some of Europe’s most complex healthcare landscapes. Today, as GM of Takeda France, she reflects on the country’s scientific strengths, its vital early access frameworks, and the evolving challenges of sustainability and digital transformation, always with patient value at…
France Curium is redefining how radiopharmaceuticals are developed, manufactured, and delivered to patients worldwide. Under the leadership of Ciril Faia, Curium International is advancing a new generation of diagnostic and therapeutic innovations, with particular focus on prostate cancer and neuroendocrine tumours (NET). Through sustained investment in talent, infrastructure, and its newly…
Taiwan Taiwan’s healthcare system stands among the most advanced and accessible in Asia, yet, as the IRPMA’s CW Chen points out, sustainability is now the central concern. Drawing on a career that has spanned leadership roles at Chugai Pharma Taiwan, GSK, and Abbott Taiwan, Chen brings a uniquely comprehensive view of…
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.…
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