The Pharma Legal Handbook: Asia Growth & Transition Market
The Pharma Legal Handbook: Baltics
Articles
Panama AFRA June 2019
Regulatory Reforms: Panama
1. Are there proposals for reform or significant change to the healthcare system? Pre-project Law No. 12 which revokes law 462 of March 18, 2025, which modifies, adds to, revokes articles of law 51 of December 27, 2005, which reforms the organic law of the social security fund and enacts other provisions. 2. When…
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…
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…
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 Question I. 2. a. above,…
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)…
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 Health and the Ministry of…
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 •…
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 The Marketing Authorization Holder (MAH)…
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…
