Tagged with HE

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.…

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…

China This week’s China healthcare and pharma roundup from PharmaBoardroom content partner Selesta highlights CF PharmTech’s HKEX listing with a 227% grey market premium, Eccogene’s HKEX IPO filing at a US$500M valuation, Zenas Bio’s US$2B licensing deal with InnoCare, and Nuruit Medical’s RMB 800M Series D financing. Clinical updates include Henlius’s…

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,…

USA In 2025, just 318 US biotech deals closed in Q2 – the lowest in a decade – even as mega-rounds propped up total investment volumes. For a sector that was booming during the pandemic era, the contrast could not be starker. Leaders from trade organisations and innovation accelerators agree on…