Tagged with ARM

Pharma Legal Handbook CANNABINOID DRUGS 68.Are Cannabinoid Drugs authorized in your country? Yes. Cannabinoids can be the active ingredient of a drug product in Canada, provided that such product meets applicable safety, effectiveness and quality requirements under the Food and Drugs Act and its regulations. This means that Cannabinoid Drugs must be submitted…

Pharma Legal Handbook 103. What is the definition of Rare Diseases in your country? In Canada, “Rare Diseases” are defined as “life-threatening, debilitating or serious, and chronic conditions affecting a small number of patients, many of which predominantly affect children, as these diseases are often genetically based and appear at birth or in…

Pharma Legal Handbook 114. 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? As of November, 2021, drugs intended for the Canadian market that could cause or exacerbate a shortage are prohibited from being distributed outside of Canada.…

Pharma Legal Handbook 123. Are biosimilar medicines considered the same as generic medicines in your country? A biosimilar is not a generic biologic product since it is not identical to its reference product; its authorization does not constitute evidence of pharmaceutical equivalence, bioequivalence or clinical equivalence.[1] A biosimilar is a subsequent entry version…

Switzerland Clinigen is in the midst of a major transformation, repositioning itself as a pure services partner focused on bridging patient access to critical medicines worldwide. Its recent acquisition of SSI Strategy underscores this shift, combining SSI’s strategic depth, established U.S. and European footprint, and innovative partnership models with Clinigen’s global…

Europe Europe has a plasma problem. The continent is over-reliant on the US for plasma – donated, purified human blood liquid – which is a key component in several lifesaving drugs for immunity, bleeding, critical care, and rare disorders.   The Donor Dilemma One explanation for these shortages is the lack…

USA The latest stories from healthcare and the life sciences in the US. RFK Jr shares his 128 recommendations for addressing childhood chronic disease; Suspension of Capsida’s gene therapy clinical trial after patient death; Courts half another attempt to challenge the IRA’s negation program; Takeda scoops up former Lilly exec to…

China The top 20 Chinese pharma companies ranked by 2023 sales, according to the Citelie Scrip Asia 100. CSPC, Fosun, and Shanghai Pharma top the chart, with a host of other less well-known firms now also generating over a billion dollars in annual sales.   Made with Visme Infographic Maker

Switzerland As Medinova marks 80 years since its founding in Zurich, General Manager Olga Lamua Olivar is charting the path forward for the boutique specialty pharma player. With a career spanning multiple countries and disciplines, she brings the breadth of experience needed to guide Medinova through its next transformation. Her strategy…

Polepharma Fabien Riolet leads Polepharma, France’s leading pharmaceutical manufacturing network, driving industrial sovereignty and innovation across 460 member companies. Under his leadership, it has evolved into a strategic hub for manufacturing excellence, digital transformation, and sustainability, while positioning France for next-generation biopharma competitiveness. Our mission is clear: to preserve and strengthen…

Switzerland Fabien Stutz, Co-Founder and CEO of Pharmabotix, leads a new wave of pharma-tech entrepreneurs combining engineering expertise with cutting-edge automation. He has helped grow the Swiss-based company into a globally recognised firm, delivering bespoke systems to major clients across Europe and North America, while retaining the agility of a boutique…

Brazil As Latin America’s largest pharma market, worth USD 62 billion in 2024, Brazil is retooling its industry to meet new demands. Driven by changing demographics, chronic disease burdens, and the growing expectations of a more affluent middle class, the Brazilian government is prioritising local production in key therapeutic niches while…