Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? On September 17, 2019, Congress approved a reform of the Criminal Code, which reforms included the decriminalization of possession of drugs that contain cannabis or derivatives as their active ingredient for therapeutic, palliative, or medicinal use or the practice of…
Pharma Legal Handbook 1. What is the definition of Rare Diseases in your country? Our law states a specific definition for rare diseases, which is the following: They are mainly considered life-threatening or debilitating in the long term. They have low prevalence and high complexity and constitute many diseases. They are characterized by…
Pharma Legal Handbook 1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? New productive investments made from January 2022, including those in the pharmaceutical sector, may be eligible for tax benefits. Investors generally benefit from a 3-point…
Mexico Hernán Porcile, General Manager of Takeda Mexico, discusses the company’s innovative therapies, regulatory strategies, and the integration of ” “Takeda-ism” within the Mexican cultural context. He emphasizes Takeda’s commitment to sustainability, diversity, and collaboration with local healthcare ecosystems. Respecting our legacy as a Japanese company while adapting to the…
Switzerland Hans Peter Borger of Spirig HealthCare discusses the company’s integration with the STADA Group and its focus on generics, consumer healthcare, and specialty markets, including Parkinson’s and rare diseases. He emphasises the importance of a growth mindset and a value-driven culture in navigating Switzerland’s regulatory landscape. We are committed…
Mexico Oswaldo Bernal explains how Mexico is BMS’ top-performing market in Latin America (outside of Brazil) and plays a significant role in the company’s global growth strategy. He also discusses how Mexican patients face hurdles in accessing new treatments due to low health investment and lengthy regulatory approval processes, as well…
Global AstraZeneca’s Anna Litsiou, Carolyn Hynes and Allison Guy, contributing to the September 2024 edition of DIA’s Global Forum magazine, discuss the importance of improving interactions between health technology assessment (HTA) bodies and regulatory authorities. The need to optimize drug development and facilitate faster access for patients has focused discussions…
Switzerland Katharina Gasser of Roche Pharma Switzerland lays out her dedication to fostering innovation, strengthening team dynamics, and influencing the future of Switzerland’s healthcare landscape. Gasser emphasizes the need to combat complacency, advance digitalization, and promote diversity in leadership, noting that “complacency is a real threat—it stifles innovation, diminishes drive, and…
Mexico Francisco Chavez from Thermo Fisher Scientific explains the company’s global mission to advance science and healthcare, with a particular focus on Latin America. Chavez highlights Thermo Fisher’s significant investment in R&D and its strategic approach to addressing regional healthcare challenges through public-private partnerships. Our commitment is to create a…
Mexico Valney Suzuki highlights his focus on expanding access to Novo Nordisk’s innovations in Mexico, especially for vulnerable populations; the importance of ethical usage of the company’s groundbreaking semaglutide-based treatments for diabetes and obesity; and Mexico’s crucial role in Novo Nordisk’s global operations, not just as a market but also in…
China Yoshio Uchida, President of Daiichi Sankyo China, outlines the company’s strategic focus on Antibody-Drug Conjugates (ADCs) within China’s oncology market and China’s relevant role in the company’s global R&D operations. He explains how Daiichi Sankyo is addressing the challenges of a dynamic healthcare environment while emphasizing the company’s commitment to…
Hong Kong Since we last covered Hong Kong in Summer 2023, the territory’s regulatory landscape has taken a major step towards its long-term goal of establishing a full regulatory authority. Having previously required approvals from two separate regulatory authorities in other countries or regions (such as the FDA in the US, the…
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