Tagged with EG

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…

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…

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 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…

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…

Brazil As one of Brazil’s leading pharmaceutical powerhouses, CIMED has redefined what it means to be both national and innovative. Built on a fully verticalised model that spans from R&D to direct distribution, the family-owned company has transformed the pharmacy landscape while empowering thousands of independent retailers across the country. Now,…

Pharma Legal Handbook Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The primary HTA authority is the Saudi Food and Drug Authority (SFDA), which hosts a dedicated HTA/Economic Evaluation Unit established in 2023. Its main responsibility is to evaluate clinical and economic evidence (EES) for: New…

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…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Health Canada is the federal authority responsible for regulating pharmaceutical drugs, biologicals, and medical devices for human use. Health Canada’s Health Products and Food Branch (“HPFB”) is the body responsible for reviewing, assessing,…