Tagged with P

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…

France France Alzheimer’s Joel Jaouen and Benoit Durand articulate a comprehensive strategic framework for addressing one of Europe’s most pressing healthcare challenges. With four decades of operational excellence, the organisation has evolved from a grassroots family initiative into France’s premier associative research funder, developing sophisticated care pathways whilst advocating for systemic…

Argentina Gala Díaz Langou, a senior analyst and executive director at Argentina’s premier think tank CIPPEC, assesses the country’s recent transformative journey under President Milei. Drawing on 25 years of institutional expertise, she outlines a framework for development based on macroeconomic stability, sustainable growth, and robust democratic institutions. Her analysis explores…

Global As chief development officer of Moderna, Dr Melanie Ivarsson OBE spearheaded the rapid development of a COVID-19 vaccine that helped the world emerge from the pandemic. Now back in the UK and drawing on over 25 years of clinical development leadership across Lilly, Pfizer, Takeda, and Moderna, Dr Ivarsson recently…

China This week’s China healthcare and pharma roundup from PharmaBoardroom content partner Selesta highlights GenFleet Therapeutics’ HKEX IPO, Sciwind’s IPO filing for enoglutide, Biocytogen’s STAR Market approval, Hengrui’s HER2 ADC licensing deal with Glenmark, and AusperBio’s US$63M Series B2 financing. Clinical updates include AbbVie’s FL filing for Epcoritamab, Ascletis’ THRβ agonist…

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…

France With only a handful of patients affected by each condition, rare diseases present a unique set of scientific, medical, and economic challenges. At the heart of this complex landscape is Recordati Rare Diseases, whose European headquarters and manufacturing footprint are anchored in France. General Manager Jean-Claude Roche shares his perspective…

Denmark When it comes to Denmark’s flourishing local biotech scene, the country is again clearly punching far above its weight. The EU member state has already managed to muster world-class expertise in areas like peptide chemistry and metabolic disorders, anchored by the success stories of homegrown entities that made it big…

Europe Affordability is not necessarily the main barrier to better rare disease therapy access in Europe. Across the continent, orphan availability correlates poorly with GDP per capita, but strongly with health technology assessment methods, speed of pricing and reimbursement, and central vs regional decision-making. Better system design – rather than simply…