The Pharma Legal Handbook: Asia Growth & Transition Market
The Pharma Legal Handbook: Baltics
Articles
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?…
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? To obtain authorization to develop and market a product, each product must obtain a sanitary registration before the Ministry of Health. STEPS A. Drugs and Biological and medicinal products Before the application for…
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…
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…
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), oversees public hospitals and primary…
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…
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…
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)…
Saudi Arabia Youssry Saleh Law Firm June 2019
Expenditure Control and Cost-Containment Policies: Saudi Arabia
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. Additional generics must be ≥10%…
