Hong Kong With a career spanning clinical medicine, hospital management, and healthcare policy, Dr Kenneth Tsang brings a rare depth of perspective to his dual role as Regional CEO of IHH Healthcare North Asia and CEO of Gleneagles Hospital Hong Kong. Having helped shape Hong Kong’s public healthcare system during his tenure…
Mexico Miguel Marti highlights Mexico as the Cardinal Health’s top market in Latin America, representing 25 percent of regional operations. Key priorities include thrombosis prevention, enteral nutrition, and surgical gloves. With a strong focus on public-private sector balance, compliance, and innovation, Marti underscores Cardinal Health’s commitment to tailored healthcare solutions, local…
France At the helm of EG Labo (STADA Group), Tiago Bartolomeu is steering one of France’s leading accessible medicine players through a period of renewal and ambition. With a clear focus on expanding access through generics, biosimilars, and consumer health, he reflects on the company’s growth strategy, its role as a…
Pharma Legal Handbook 1.Please make a general introduction to the public health sector in your country and its organization Saudi Arabia provides universal health coverage primarily funded by the government through a tax-based model. The healthcare system is organized in a tiered structure led by the Ministry of Health (MOH), which operates: •…
Pharma Legal Handbook Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? The Ministry of Health (MOH) is the primary body responsible for public health in Saudi Arabia. It sets national health policies, issues licenses to healthcare providers (public and private),…
Pharma Legal Handbook What are the pricing models, processes and principles for originator drugs? Originator drugs (innovator medicines) are priced by the Saudi Food and Drug Authority (SFDA) following the principles outlined in its 2023 Drug Pricing Guidelines. The pricing process includes: External Reference Pricing (ERP): SFDA compares prices with a reference basket…
Pharma Legal Handbook What are the pricing models, processes and principles for originator drugs? Drugs are provided by a medical institution or pharmacy to a patient based on the NHI Drug Price (a patient pays 10%, 20% or 30% (depending on age and other conditions) of the NHI Drug Price). As detailed in…
Pharma Legal Handbook Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Yes. The SFDA published the Economic Evaluation Studies Guideline (PDF, July 10, 2024), which outlines comprehensive methods and includes a checklist. Followed by the Pharmacoeconomic Submission Portal Manual (January 2025), detailing dossier preparation and submission protocols.…
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.…
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