Tagged with Market

Taiwan Access to capital is the difference between life and death for small biotechs and life science start-ups. But in an industry with high levels of failure and decades-long development cycles, finding the right investors – those with sufficiently deep pockets and enough of an appetite for risk – can be…

Hong Kong After a rocky couple of years, Hong Kong has defied its sceptics and definitively bounced back. As Asia’s financial capital and the bridge between mainland China and international markets, the global stock market slump between 2021 and 2024 had an outsized impact on Hong Kong, with sluggish GDP growth and…

Hong Kong It is not unreasonable, at first glance, to ask why so many pharma multinationals have chosen to establish standalone affiliates in Hong Kong. After all, only 7.5 million people call Hong Kong home, putting a cap on growth potential, and it could easily be covered by affiliates based in the…

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.…