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 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 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…
LatAm Arturo De la Rosa, Vice President for Latin America at Gilead Sciences, leverages deep regional experience to navigate healthcare challenges and opportunities across multiple countries. He oversees a dual strategy, sustaining leadership in virology while expanding Gilead’s oncology presence, aiming for it to represent a third of global revenues by…
France Created in the wake of COVID-19, the Agence de l’Innovation en Santé (AIS), part of the Secrétariat Général pour l’investissement – a Prime Minister department, has rapidly positioned itself at the heart of France’s health innovation strategy, driving progress in areas such as bioclusters, prevention, clinical research, and artificial intelligence.…
France LEO Pharma – a global heavyweight in the dermatology field – is undergoing a period of renewal, combining a stronger focus on innovation with a cultural transformation aimed at greater agility and collaboration. At the centre of this evolution in France is Karine Duquesne, who is drawing on more than…
China This week’s China healthcare roundup from PharmaBoardroom content partner Selesta highlights Kite Pharma’s US$1.64B in vivo CAR-T deal with Pregene, Xuanzhu Biopharma’s HKEX debut with a 172% grey market premium, Hansoh’s US$1.53B CDH17 ADC licensing to Roche, and Leads Biolabs’ US$1B autoimmune drug deal with Dianthus. Biokin secured a record…
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