Tagged with Pharma

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 Curium is redefining how radiopharmaceuticals are developed, manufactured, and delivered to patients worldwide. Under the leadership of Ciril Faia, Curium International is advancing a new generation of diagnostic and therapeutic innovations, with particular focus on prostate cancer and neuroendocrine tumours (NET). Through sustained investment in talent, infrastructure, and its newly…

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…

Switzerland As global trade tensions escalate, Switzerland’s export-driven pharmaceutical industry finds itself at a challenging moment. With the United States imposing tariffs of up to 39 percent on Swiss goods and threatening further measures, the pressure on Switzerland’s most important industrial sector – responsible for ten percent of GDP and over…

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,…

Pharma Legal Handbook 16. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? There is no requirement to conduct local trials of a new drug to receive marketing approval. Rather, in order to obtain marketing approval, a company must submit an NDS application containing information…