China Chinese drugmakers are increasingly looking past the NMPA toward approvals in the EU, US, and Australia. Daphne Smyth of Veristat has watched this shift from the front row, guiding sponsors through the data gaps, bridging studies, and regulatory quirks that stand between a China-developed drug and a Western marketing authorisation.…
USA Neuroscience is back. After a litany of divestments and scale backs in the 2010s, diseases of the brain are now the second-most-funded area in biotech, behind only cancer. However, this remains a complex and challenging field, leading neuroscience biotechs – three of which are profiled below – to develop very…
Africa Can a medicine be considered “available” if it can’t be trusted? As Africa’s manufacturing base expands and its regulatory systems mature, that question is moving to the centre of the continent’s health agenda. Lenias Hwenda maps out why 2026 is a turning point for African patient safety — anchored by…
MEA Once regarded as a strategic afterthought by international biopharma, the Middle East has undergone a profound transformation in recent years, emerging as an early adopter of next-generation therapies for rare diseases. Regional regulatory authorities are accelerating approval timelines, reflecting an aggressive institutional ambition to secure speedy access to cutting-edge medical…
Europe Strong patent portfolios can create substantial commercial value for biopharma companies. As Isobel Barry, partner at life sciences-focused IP firm Carpmaels & Ransford LLP explains, opportunities to patent new small molecule, biologics and complex therapeutics arise throughout the go-to-market process, from early-stage research, through formulation development and clinical trials, up…
Taiwan Semiconductors: Silicon Powerhouse Taiwan and semiconductors – the microscopic chips inside virtually every electronic device – are inextricably linked. For a modestly sized island, Taiwan’s semiconductor dominance is extraordinary: through the state-backed TSMC (Taiwan Semiconductor Manufacturing Company), the island functions as the world’s foundry, manufacturing the advanced chips designed by…
Europe As the European Medicines Agency navigates the most significant expansion of its mandate in a generation, Executive Director Emer Cooke highlights how the regulator is further strengthening its role across the full lifecycle of medicines. Cooke sets out how EMA is enhancing its engagement from early developer support and clinical…
Germany Germany’s Medical Research Act is almost two years old. Writing in the June/July 2026 edition of DIA Global Forum, Thomas Sudhop, Claudia Riedel and Karl Broich of the Federal Institute for Drugs and Medical Devices (BfArM) outline how the Act attempts to revitalise clinical research in Germany, balancing faster procedures…
Germany Professor Stefan Vieths, president of Germany’s Paul-Ehrlich-Institut (PEI), explains how Europe’s most specialised biomedicines regulator is navigating a period of rapid transformation. Vieths traces the PEI’s 130-year evolution from a serum-testing institute into the federal authority overseeing vaccines, blood products, and advanced therapies; examines how Germany’s Medical Research Act is…
USA As cell and gene therapies move closer to broader clinical reality, questions around manufacturing, scalability, and regulatory flexibility are becoming just as important as the science itself. Denise Gavin and Steven Oh of the FDA’s Office of Therapeutic Products discuss how the agency is adapting its chemistry, manufacturing, and controls…
Europe Against a backdrop of rising geopolitical tension, regulatory fragmentation, and mounting pressure on Europe’s healthcare systems, Prague-headquartered Zentiva is positioning itself as a distinctly European pharmaceutical player focused on long-term resilience, affordability, and supply security. CEO Steffen Saltofte reflects on the company’s transformation since its carve out from Sanofi, its…
USA The US Food and Drug Administration (FDA) finds itself in the midst of unprecedented political turmoil. The Trump Administration’s Department of Government Efficiency (DOGE) removed 3,500 of the Agency’s 20,000 employees in 2025, and a relentless succession of leadership upheavals has compounded the disruption. After 17 months of regulatory and…
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