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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…

Pharma Legal Handbook 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…

Pharma Legal Handbook BIOSIMILARS AND BIOLOGICS in Panama are regulated by Law No. 419 of February 1, 2024, Executive Decree No. 95 of May 14, 2019.   1. Are biosimilar medicines considered the same as generic medicines in your country? No. Generic medicines are defined as medicines distributed or sold that are marked…

Taiwan With its thriving innovation ecosystem and growing global visibility, Taiwan is fast emerging as one of Asia’s most dynamic biotechnology hubs. At the forefront of this transformation is Wallace Lin, Secretary-General of Taiwan Bio, who has spent his career bridging science, policy, and industry to strengthen the nation’s life sciences…

France With over 35 years of experience across major pharmaceutical markets, Corinne Blachier-Poisson, General Manager of Amgen France, she discusses Amgen France’s ambitions and the company’s pivotal role in shaping France’s life sciences ecosystem. Our strength lies in combining scientific rigour, industrial reliability, and collaboration to deliver lasting value for patients…

Taiwan Dr Chih-Kang Chiang, Director-General of the TFDA, shares how Taiwan is redefining regulation through science, transparency, and international collaboration. Combining his backgrounds in medicine, toxicology, and law, he leads efforts to strengthen patient safety, accelerate innovation in AI and regenerative medicine, and reinforce supply resilience. This conversation offers insight into…

France After two decades with AstraZeneca across Europe and the United States, Anne-Laure Dreno now leads the group’s French affiliate at a time of exceptional scientific and organisational momentum. In this conversation, she reflects on AstraZeneca France’s rapid growth, the country’s evolving research and access landscape, and the company’s pioneering commitment…