Tagged with B

LatAm Haig Yeghiaian, General Manager at LEO Pharma Brazil, brings extensive therapeutic area expertise spanning HIV, nephrology, and dermatology to his leadership of the company’s multifaceted Brazilian operations. Under his stewardship, LEO Pharma has evolved from a traditional retail-focused dermatology company into a diversified enterprise operating across six distinct market segments…

Europe Cancer is one of Europe’s most urgent health challenges. Responsible for 23 percent of all mortality on the continent, the burden is particularly acute outside the EU5, where access timelines vary dramatically. Countries in Central and Eastern Europe, for example, face some of Europe’s highest cancer mortality rates, largely due…

Brazil After international tenures in Korea and at Servier’s global headquarters in Paris, Matthieu Mendil has taken the helm of Servier Brazil at a pivotal moment in the affiliate’s evolution. Drawing on a global perspective shaped by strategy and operational leadership, he is guiding Servier Brazil to balance its strong cardiometabolic…

Hong Kong Hong Kong is entering a pivotal new chapter in its healthcare and regulatory evolution. Under the leadership of Secretary for Health Professor Lo Chung-mau, the city is reshaping its position as a global bridge for medical innovation through the “1+ Mechanism,” the creation of the Centre for Medical Products Regulation,…

Pharma Legal Handbook 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.…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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,…

Pharma Legal Handbook The legal framework for product liability 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 types of liability are recognized in your jurisdiction? Contractual and extracontractual responsibility. These can…

Pharma Legal Handbook 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…

Pharma Legal Handbook 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…

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…