The Pharma Legal Handbook: Asia Growth & Transition Market
The Pharma Legal Handbook: Baltics
Articles
Saudi Arabia Youssry Saleh Law Firm June 2019
Post Market-Approval Processes and Regulations: Saudi Arabia
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 of 34 countries. Internal Reference…
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Authority that regulates drugs, biologicals and medical devices in Panama is the Ministry of Health through the following authorities: Pharmaceutical and Drug Department Medical Devices National Department Bioethical National Committee. See the Chapter: Directory of…
Panama AFRA June 2019
Orphan Drugs & Rare Diseases: Panama
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 in your country? Rare, less…
Panama AFRA June 2019
Patents and Trademarks: Panama
1. What are the basic requirements to obtain patent and trademark protection? The basic requirements for obtaining a patent are the following: Power of attorney granted by the applicant; no legalization nor notarization required Assignment Document legalized by Panamanian Consulate or Apostille Specifications, claims, abstract and drawings (if applicable). If the applicant is a natural…
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: • Over 287 public hospitals •…
A brief overview of the situation regarding traditional medicines and OTC products in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?…
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. Have local Authorities published…
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 universities. SFDA (Saudi Food and…
Preclinical & Clinical Trials in Panama are regulated by Law 78 November 20, 2003; Law 84 of May 14, 2019; Executive Decree 1110 June 6, 2012; Resolution No. 512 of June 28, 2019; Executive Decree 1843 December 16, 2014. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit)…
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 chemical entities Biologics Re-pricing of…
