Tagged with Pharma

Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoids are substances subject to national control for therapeutic, medical, veterinary, scientific and research use.    2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? The regulatory authorities are the Pharmaceutical and Drug Department from the Ministry of…

Pharma Legal Handbook Orphan Drugs in Panama are regulated by Law No. 419 of February 1, 2024, Executive Decree No. 13 of March 1, 2023 and Executive Decree 1217 of December 7, 2015; Rare Diseases are regulated by Law 28 of October 28, 2014.   1. What is the definition of Rare Diseases…

Pharma Legal Handbook BIOSIMILARS AND BIOLOGICS in Panama are regulated by Law No. 419 of February 1, 2024, Executive Decree No. 95 of May 14, 2019.   1. Are biosimilar medicines considered the same as generic medicines in your country? No. Generic medicines are defined as medicines distributed or sold that are marked…

Switzerland As global trade tensions escalate, Switzerland’s export-driven pharmaceutical industry finds itself at a challenging moment. In May 2025, the United States imposed tariffs of up to 39 percent on Swiss goods, putting pressure on Switzerland’s most important industrial sector, which is responsible for ten percent of GDP and 41 percent…

Switzerland With the Trump administration imposing tariffs of up to 39 percent on Swiss goods (recently reduced to 15 percent), the pressure on Switzerland’s most influential industrial sector – pharmaceuticals – has undoubtedly intensified. Yet the industry continues to wield a super-size effect on the local economy, contributing up to a…

Switzerland For a tiny Alpine nation nestled deep in the interior of continental Europe, Switzerland boasts a spectacularly vibrant biotech scene. This is because “the country manages to leverage its compact geography to achieve unprecedented levels of collaboration across key innovation hubs, rendering it possible to forge strong networks and partnerships…

France France’s minority government has forced through a Social Security & Healthcare Bill for 2026 containing EUR five billion in healthcare cuts. For the country’s beleaguered innovative pharma industry, this Bill represents yet another setback, with stakeholders warning of more access delays, listing withdrawals, and unnecessary patient suffering.   PLFSS 2026:…

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.…