Tagged with Pharma

Brazil Latin America’s largest and most dynamic pharma market is booming. Despite sluggish macroeconomic growth, agile local firms are consolidating their positions to serve Brazilian patients, while a spate of technology transfer agreements is bolstering local manufacturing capabilities and helping these companies scale the value chain. Multinationals – with the right…

Taiwan PharmaEngine is entering a defining phase as it strengthens its development-only roots while expanding into early discovery, differentiated DNA damage response programmes and AI-enabled design. In this conversation, CEO Hong-Ren Wang outlines how ONIVYDE® provides the stability to advance a more ambitious pipeline, how a virtual model sharpens scientific focus…

France Skyepharma stands at a defining moment. With new shareholders, expanding high-potency and bioproduction capabilities and a sharpened focus on complex oral forms, the French CDMO is positioning itself for a new phase of growth at the intersection of innovation, sovereignty and international ambition. In this conversation, recently appointed CEO Sébastien…

France ISISPHARMA’s story unfolds through the Dewavrin group’s evolution from textile manufacturing into a science driven portfolio spanning dermocosmetics and micronutrition. Grégoire Dewavrin explains how the brand has grown through a resolutely medical positioning, early international expansion and a strategy built on proximity to clinicians and local partners. As the organisation…

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…

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…