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.…
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…
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…
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…
LatAm Sarah Aiosa, SVP and President of MSD (known as Merck & Co. in the U.S. and Canada) for Latin America, highlights nearly four years of strong growth built on a clear mission to expand access to healthcare. Under her leadership, MSD has advanced vaccines, oncology treatments, and clinical research in…
LatAm Sinan Atlig reflects on a 25-year global career spanning Turkey, Colombia, the Middle East, and the US, shaped decisively by vaccine leadership through the COVID-19 era. He identifies vaccines and oncology as Pfizer’s twin strategic priorities for Latin America, supported by expanding roles in obesity, rare diseases, and anti-infectives. His…
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,…
Global A century after insulin’s discovery transformed Type 1 diabetes from fatal to manageable, access remains deeply unequal. Writing exclusively for PharmaBoardroom, Access to Medicine Foundation CEO Jayasree Iyer explores why half of those who need insulin worldwide still go without it and how only systemic, long-term collaboration between industry, governments,…
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